Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016965564

FEI Number

3016965564

Entity Name

AUREL GmbH

City/State/Country

Bensheim Hesse, DE

Establishment Address

Dr.-Linck-Weg 14, Bensheim Hesse 64625, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Prisman GmbH (Owner Number: 10090401)

Owner / Operator Contact Address

Otto-Hahn-Str 6-18, Lorsch, DE-HE 64653, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prophypowder FRESH - Mint Prophypowder FRESH Prophypowder PERIO PLUS Prophypowder TOP - Mint Prophypowder SOFT PERIO Prophypowder TOP Prophypowder PERIO PLUS - Mint Prophypowder SOFT PERIO - Mint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2024-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

Prisman GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030895232	Prisman, Inc.	Seven Fields, PA, US
3027692624	PRISMAN GMBH	Lorsch Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

Similar Registrations

Registration Number	Establishment Name	Location
3010864832	3D DENTAL DESINGS AND DEVELOPMENT	Shaker Heights, OH, US
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH
9616065	MANUFACTURERA DENTAL CONTINENTAL	ZAPOPAN Jalisco, MX
3004096429	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.	NYON Vaud, CH
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016965564. Last updated year: 2026. Please use registration number 3016965564 when referencing this establishment in official correspondence.