Identity
- Trade Name
- OptraGloss Assortment EUDAMEDOptraGloss FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- OptraGloss EUDAMEDOptraGloss Assortment FDA UDI
- Model / Reference
- 684548AN EUDAMEDFDA UDI
- Description
- OptraGloss Assortment FDA UDI
Identifiers
- Catalog Number
- 684548AN FDA UDI
- Primary DI / UDI-DI
- 07615208294682 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082APOLI001RD EUDAMED
- FDA Product Code
- EHJ 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
- Liechtenstein 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive point, reusable
OptraGloss by Ivoclar Vivadent Aktiengesellschaft — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive point, reusable.
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- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Strauss Diamond — Diamond Strauss Instruments Inc · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI a3a96310-412c-4526-8c0b-1d1136d2686b 34 fields · synced Jun 18, 2026
- EUDAMED 0138ebee-f136-42e7-9f49-7faec151f025 61 fields · synced Jun 18, 2026