Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1836392

FEI Number

3003136707

Entity Name

EXACTA DENTAL PRODUCTS, INC.

City/State/Country

CLINTON TOWNSHIP, MI, US

Establishment Address

44780 MACOMB INDUSTRIAL DR., CLINTON TOWNSHIP, MI 48036, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

EXACTA DENTAL PRODUCTS, INC. (Owner Number: 9043538)

Owner / Operator Contact Address

44780 MACOMB INDUSTRIAL DR., --, CLINTON TOWNSHIP, MI 48036, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EXACTA Temp Xtra FRESH Bold Impression Material EXACTA Mixing Tips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2012-05-01
ELW	Material, Impression	Dental	Class 2	872.3660	2009-01-23
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2012-05-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EXACTA DENTAL PRODUCTS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13

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3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR
1410097	GC AMERICA INC.	ALSIP, IL, US
3015396763	MGNEWTON LTD.	Gyengsan-si Gyeongbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1836392. Last updated year: 2026. Please use registration number 1836392 when referencing this establishment in official correspondence.