Identity
- Trade Name
- SUPERFIX FDA UDI
- Generic Name
- Dental abrasive disk, single-use FDA UDI
- Device Name
- Superfix - 50 Coarse Discs + Mandrel (PT/ES/EN/FR) FDA UDI
- Model / Reference
- 0002010009 FDA UDI
- Description
- Superfix - 50 Coarse Discs + Mandrel (PT/ES/EN/FR) FDA UDI
Identifiers
- Catalog Number
- 0002010009 FDA UDI
- Primary DI / UDI-DI
- 07897990300936 FDA UDI
- FDA Product Code
- EHJ FDA UDI
- GMDN Term
- Dental abrasive disk, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive disk, single-use
Superfix by Tdv Dental Ltda — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive disk, single-use.
- FlexiDisc Regular 3/4 Coarse — Cosmedent, Inc. · Class I
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- The Orthodontic Store — Young Innovations, Inc. · Class I
- FlexiDisc Mini Starter Kit 3/8 — Cosmedent, Inc. · Class I
- SeptoDiscs Refill: 1/2” - 50 fine abrasive discs — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
- FlexiDisc Mini 5/8 Superfine — Cosmedent, Inc. · Class I
- FlexiDisc 1/2 Coarse — Cosmedent, Inc. · Class I
- FlexiDisc Mini 5/8 Extrafine Garnet — Cosmedent, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tdv Dental Ltda
Sources (1)
- FDA UDI dfe99b65-78f6-4fa1-9f65-c244cb6d177c 35 fields · synced Jun 1, 2026