Teca Dent Instruments

⚠️ Moderate Risk

FEI: 3008977549 • Sialkot • PAKISTAN

FEI

FEI Number

3008977549

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN

🏢

Address

P/O Box#485, Daska Rd, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

41.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

4/28/2015

Latest Refusal

4/28/2015

Earliest Refusal

Score Breakdown

Violation Severity

53.3×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

90.0×10%

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

1189×

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).

2909×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

3419×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
4/28/2015	76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)
4/28/2015	76EMACEMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)
4/28/2015	76EMNSCALER, PERIODONTIC	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)
4/28/2015	76EKBEXPLORER, OPERATIVE	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)
4/28/2015	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)
4/28/2015	76EJYPLIERS, OPERATIVE	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)
4/28/2015	76EKCEXCAVATOR, DENTAL, OPERATIVE	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)
4/28/2015	76EKJBURNISHER, OPERATIVE	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)
4/28/2015	76EIXPROBE, PERIODONTIC	118NOT LISTED 290DE IMP GMP 341REGISTERED	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Teca Dent Instruments's FDA import refusal history?

Teca Dent Instruments (FEI: 3008977549) has 9 FDA import refusal record(s) in our database, spanning from 4/28/2015 to 4/28/2015.

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. Teca Dent Instruments's FEI number is 3008977549.

What types of violations has Teca Dent Instruments received?

Teca Dent Instruments has been cited for 3 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 Teca Dent Instruments come from?

All FDA import refusal data for Teca Dent Instruments 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.