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Diaceram 3-step flame, pu: 6 pcs
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 154RAModel Diaceram 3-step twist
by Diaswiss SA
Identity
- Trade Name
- Diaceram 3-Step EUDAMEDDiaceram 3-step flame, pu: 6 pcs FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Dental Rotary Polishing Instrument EUDAMEDDental rotary polishing instrument for intraoral use FDA UDI
- Model / Reference
- Diaceram 3-step twist EUDAMED154RA EUDAMED160RA FDA UDI
- Description
- Dental rotary polishing instrument for intraoral use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630049904750 EUDAMED07630049995307 FDA UDI
- Basic UDI-DI
- B-07630049904750 EUDAMED
- FDA Product Code
- EHL FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive point, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive point, reusable
Diaceram 3-step flame, pu: 6 pcs by Diaswiss SA — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental abrasive point, reusable.
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- Alpen — Coltene/Whaledent Inc. · Class I
- Strauss Diamond — Diamond Strauss Instruments Inc · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diaswiss SA
Sources (2)
- FDA UDI 47028d00-3346-4284-9196-0ff37c90d159 33 fields · synced Sep 30, 2026
- EUDAMED 90c9368b-b599-41fb-ba6d-c4ac051620be 61 fields · synced Sep 30, 2026