Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030962

FEI Number

5615

Entity Name

Micro-Mega SA

City/State/Country

BESANCON Doubs, FR

Establishment Address

12 RUE DU TUNNEL, BESANCON Doubs 25000, FR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

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

CanalPro EDTA MM-EDTA CREAM K REAMERS K REAMERS Prime Line K-Reamers STERILE DISPOSABLE NEEDLE (L,K,F,.......) One curve 2Shape R-ENDO ONE CURVE STARTER PACK ONE-G HERO SHAPER MicroMega REMOVER HERO 642 2Shape Procedure Pack HyFlex CM HEDSTROEM FILES K FILES H-Files ONE FLARE HYFLEX REMOVER ONE CURVE PROCEDURE PACK MME Files HEDSTROEM FILES Prime Line K FILES Prime Line REMOVER MMC FILES K-Files MicroMega One Reci Procedure Pack 2 Shape Mini MicroMega One Curve Mini 2 Shape Mini Procedure Pack MicroMega One Curve Mini Procedure Pack MicroMega One Reci MM K-Files, MM H-Files, MM K-Reamers MicroMega Reci Glider MM TAPER MicroMega One Glider

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2018-09-19
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2019-02-27
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	2019-02-27
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2010-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

Tricia Cregger Business: Coltene/Whaledent Inc Email: tricia.cregger@coltene.com Phone: (330) 9168904

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
3012832388	DIATECH DENTAL INC	Mount Pleasant, SC, US
2416455	COLTENE/WHALEDENT INC.	CUYAHOGA FALLS, OH, US
8043629	SCICAN LTD.	TORONTO Ontario, CA
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K954031	R. A. Fischer Co. Corp.	COMPU-BLEND EPILATOR	1996-01-05
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Similar Registrations

Registration Number	Establishment Name	Location
3016447764	DSI DENTAL SOLUTIONS LTD	Ashdod Southern, IL
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3043655586	FOSHAN ORECK MEDICAL TECHNOLOGY CO.,LTD	Foshan City Guangdong, CN
3006113314	SPIDENT CO., LTD.	INCHEON Gyeonggi, KR
2436986	META DENTAL CORP.	Glendale, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030962. Last updated year: 2026. Please use registration number 8030962 when referencing this establishment in official correspondence.