Prime Dental Products Pvt Ltd

⚠️ Moderate Risk

FEI: 3011809971 • Bhiwandi • INDIA

FEI

FEI Number

3011809971

📍

Location

Bhiwandi

🇮🇳

Country

INDIA

🏢

Address

Shree Arihant Compound E8 Gala, , Bhiwandi, , India

Moderate Risk

FDA Import Risk Assessment

49.8

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

7/6/2016

Latest Refusal

2/2/2016

Earliest Refusal

Score Breakdown

Violation Severity

56.7×40%

Refusal Volume

57.2×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

11834×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

328034×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

50829×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

Date	Product	Violations	Division
7/6/2016	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	118NOT LISTED 3280FRNMFGREG	New Orleans District Office (NOL-DO)
7/6/2016	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	118NOT LISTED 3280FRNMFGREG	New Orleans District Office (NOL-DO)
7/6/2016	76OFXGENERAL PURPOSE DENTAL TRAY	118NOT LISTED 3280FRNMFGREG	New Orleans District Office (NOL-DO)
2/2/2016	76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EGDWAX, DENTAL, INTRAORAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EJLBUR, DENTAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EJLBUR, DENTAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	79FTXMIRROR, GENERAL & PLASTIC SURGERY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76DZSCAPSULE, DENTAL, AMALGAM	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EILGAUGE, DEPTH, INSTRUMENT, DENTAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EBCSEALANT, PIT AND FISSURE, AND CONDITIONER	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EMACEMENT, DENTAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EJKLINER, CAVITY, CALCIUM HYDROXIDE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76ELMDENTURE, PLASTIC, TEETH	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76OFXGENERAL PURPOSE DENTAL TRAY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EKMGUTTA-PERCHA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EHEDISPENSER, MERCURY AND/OR ALLOY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EKRPLUGGER, ROOT CANAL, ENDODONTIC	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EMJELEVATOR, SURGICAL, DENTAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	79FTYTAPE, MEASURING, RULERS AND CALIPERS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EKJBURNISHER, OPERATIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	79GESBLADE, SCALPEL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	79HTDFORCEPS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76KXRAPPLICATOR, RESIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EMKCURETTE, SURGICAL, DENTAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EIGRETRACTOR, ALL TYPES	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	80FMADEPRESSOR, TONGUE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EMIFILE, BONE, SURGICAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EAXMIRROR, MOUTH	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	76EIKCARVER, WAX, DENTAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/2/2016	60QCQ07LIDOCAINE	118NOT LISTED 3280FRNMFGREG 75UNAPPROVED	Division of Southeast Imports (DSEI)
2/2/2016	60LBY75EUGENOL (ANALGESIC)	118NOT LISTED 3280FRNMFGREG 75UNAPPROVED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Prime Dental Products Pvt Ltd's FDA import refusal history?

Prime Dental Products Pvt Ltd (FEI: 3011809971) has 34 FDA import refusal record(s) in our database, spanning from 2/2/2016 to 7/6/2016.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Prime Dental Products Pvt Ltd's FEI number is 3011809971.

What types of violations has Prime Dental Products Pvt Ltd received?

Prime Dental Products Pvt Ltd has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Prime Dental Products Pvt Ltd come from?

All FDA import refusal data for Prime Dental Products Pvt Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.