Drug establishmentActive, Registered FY2026FDA warning letter on file

DENTAL TECHNOLOGIES, INC.

DENTAL TECHNOLOGIES, INC. is an FDA-registered drug establishment (FEI 1413475) located in LINCOLNWOOD, Illinois. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-08-14) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Nov 30, 2021

CGMP/QSR/Medical Devices/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number

1413475

Address

6901 N. HAMLIN AVENUE, LINCOLNWOOD, Illinois

Establishment type

Drug establishment

Products / operations

Labeling, Manufacturing, Packaging, Relabeling

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Aug 14, 2024 · Voluntary Action Indicated (VAI)
Aug 14, 2024 · Voluntary Action Indicated (VAI)
Jul 26, 2022 · Official Action Indicated (OAI)
Jul 26, 2022 · Official Action Indicated (OAI)
Jan 20, 2021 · Official Action Indicated (OAI)
Mar 12, 2019 · Voluntary Action Indicated (VAI)
Apr 24, 2018 · No Action Indicated (NAI)
Jun 29, 2017 · No Action Indicated (NAI)
Jan 9, 2015 · No Action Indicated (NAI)
Jan 9, 2015 · No Action Indicated (NAI)
Mar 23, 2012 · No Action Indicated (NAI)
Mar 23, 2012 · Voluntary Action Indicated (VAI)

Form 483 observations

Aug 14, 2024, 9 observations: Procedures not in writing, fully followed; SOPs not followed / documented; Equipment construction - reactive surfaces
Mar 12, 2019, 1 observation: Microbiological testing
Mar 23, 2012, 4 observations: Complete test data included in records; Actual vs. theoretical yields not determined; Scientifically sound laboratory controls
Apr 12, 2011, 7 observations: Control procedures to monitor and validate performance; Microbiological testing; Extent of discrepancy, failure investigations
Jul 27, 2009, 5 observations: Design validation- Lack of or inadequate procedures; Design control - no procedures; Identifying corrective & preventive actions

Questions

Is DENTAL TECHNOLOGIES, INC. registered with the FDA?

Yes. DENTAL TECHNOLOGIES, INC. is an FDA-registered drug establishment (FEI 1413475) in LINCOLNWOOD, Illinois. Its current registration status is Active, Registered FY2026.

Has DENTAL TECHNOLOGIES, INC. received an FDA warning letter?

Yes. FDA issued a warning letter to DENTAL TECHNOLOGIES, INC.; the most recent is dated Nov 30, 2021 (CGMP/QSR/Medical Devices/Adulterated).

What does DENTAL TECHNOLOGIES, INC. do?

DENTAL TECHNOLOGIES, INC.'s FDA-registered operations are: Labeling, Manufacturing, Packaging, Relabeling.

Related facilities

Accupack Midwest Chemco Corporation Aerosol and Liquid Packaging, Inc.Fareva Morton Grove, Inc.Sunstar Americas, Inc.Missouri Analytical Laboratories, Inc.

Source: FDA public data · status as of 2026-06-06