OraMetrix GmbH

FDA Device Registration & Listing · Berlin Brandenburg, DE · Registration 3003136642

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003136642
FEI Number
3003136642
Entity Name
OraMetrix GmbH
City/State/Country
Berlin Brandenburg, DE
Establishment Address
Rungestrasse 19, Berlin Brandenburg 10179, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
DENTSPLY SIRONA INC (Owner Number: 2511302)
Owner / Operator Contact Address
221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SureSmile Advanced Software v 7.6 SureSmile Ortho Software v 7.6 SureSmile Aligner Software v 7.6

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIA Unit, Operative Dental Dental Class 1 872.6640 2019-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9612618 DEGUDENT GMBH Rosbach V.D.H. Hesse, DE
3003756493 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR
3001226627 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) ST. EGREVE Isere, FR
3000303964 DENTSPLY DENTAL (TIANJIN) CO., LTD. TEDA Tianjin, CN
9611053 VDW GMBH MUNICH Bavaria, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003136642. Last updated year: 2026. Please use registration number 3003136642 when referencing this establishment in official correspondence.
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