MAINLINE MEDICAL DENTAL SUPPLY

⚠️ High Risk

FEI: 3012421607 • North York, Ontario • CANADA

FEI

FEI Number

3012421607

📍

Location

North York, Ontario

🇨🇦

Country

CANADA

🏢

Address

100-102 Rossdean Dr, , North York, Ontario, Canada

High Risk

FDA Import Risk Assessment

57.0

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

12/14/2023

Latest Refusal

12/14/2023

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

51.1×30%

Recency

58.0×20%

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

11823×

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).

Refusal History

Date	Product	Violations	Division
12/14/2023	76EBLPIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	76ELWMATERIAL, IMPRESSION	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	76EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	76EMACEMENT, DENTAL	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	89KFXASSEMBLY, THIGH/KNEE/SHANK/ANKLE/FOOT, EXTERNAL	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	89ITGBANDAGE, CAST	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	85NKCTUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	79FZZMARKER, SKIN	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	79FZZMARKER, SKIN	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	80GAZTUBING, NONINVASIVE	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	80GAZTUBING, NONINVASIVE	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	78KODCATHETER, UROLOGICAL	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	78KODCATHETER, UROLOGICAL	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	74DRXELECTRODE, ELECTROCARDIOGRAPH	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	76EKRPLUGGER, ROOT CANAL, ENDODONTIC	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	76EISREMOVER, CROWN	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	76EJZKNIFE, MARGIN FINISHING, OPERATIVE	118NOT LISTED	Division of Northern Border Imports (DNBI)
12/14/2023	79LRPTRAY, SURGICAL	118NOT LISTED	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is MAINLINE MEDICAL DENTAL SUPPLY's FDA import refusal history?

MAINLINE MEDICAL DENTAL SUPPLY (FEI: 3012421607) has 23 FDA import refusal record(s) in our database, spanning from 12/14/2023 to 12/14/2023.

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. MAINLINE MEDICAL DENTAL SUPPLY's FEI number is 3012421607.

What types of violations has MAINLINE MEDICAL DENTAL SUPPLY received?

MAINLINE MEDICAL DENTAL SUPPLY has been cited for 1 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 MAINLINE MEDICAL DENTAL SUPPLY come from?

All FDA import refusal data for MAINLINE MEDICAL DENTAL SUPPLY 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.