Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012832388

FEI Number

3012832388

Entity Name

DIATECH DENTAL INC

City/State/Country

Mount Pleasant, SC, US

Establishment Address

497 LA MESA RD, Mount Pleasant, SC 29464, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Coltene/Whaledent AG (Owner Number: 9089944)

Owner / Operator Contact Address

Altstaetten, Feldwiesenstrasse 20, Altstaetten, CH-SG CH 9450, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Diatech Diamond Instruments Alpen Diamond Instruments Alpen Alpen Speedster Zr Plus DIATECH Z-Rex DIATECH Alpen Z-Rex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2009-10-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Coltene/Whaledent AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8030962	Micro-Mega SA	BESANCON Doubs, FR
2416455	COLTENE/WHALEDENT INC.	CUYAHOGA FALLS, OH, US
8043629	SCICAN LTD.	TORONTO Ontario, CA
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH

Similar Registrations

Registration Number	Establishment Name	Location
2523990	SPRING HEALTH PRODUCTS, INC.	NORRISTOWN, PA, US
1526534	Sterigenics US, LLC	Lewis Center, OH, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
8030938	DIRECTA AB	UPPLANDS VAESBY Stockholm, SE
3003444492	PRIMA DENTAL GROUP	GLOUCESTER Gloucestershire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012832388. Last updated year: 2026. Please use registration number 3012832388 when referencing this establishment in official correspondence.