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DIAMOND ABRASIVE STRIPS, 4 mm MEDIUM, 1S, perforated
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- DIAMOND ABRASIVE STRIPS, 4 mm MEDIUM, 1S, perforated FDA UDI
- Generic Name
- Dental abrasive strip, single-use FDA UDI
- Device Name
- Abrasive strips are used during restorative treatments to adjust / shape / smooth / reduce the interproximal area & contact points of the tooth‘s crown (artificial or natural). The abrasive strips are made of stainless-steel base coated with abrasive grit (corundum or diamond). The products are used in the dentistry field. Pack of 10 pcs FDA UDI
- Model / Reference
- 46052 FDA UDI
- Description
- Abrasive strips are used during restorative treatments to adjust / shape / smooth / reduce the interproximal area & contact points of the tooth‘s crown (artificial or natural). The abrasive strips are made of stainless-steel base coated with abrasive grit (corundum or diamond). The products are used in the dentistry field. Pack of 10 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- J01046052 FDA UDI
- FDA Product Code
- EHM FDA UDI
- GMDN Term
- Dental abrasive strip, 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
Yes
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
Category: Dental abrasive strip, single-use
DIAMOND ABRASIVE STRIPS, 4 mm MEDIUM, 1S, perforated by Produits dentaires S.A. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Dental abrasive strip, single-use.
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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
- Produits dentaires S.A.
Sources (2)
- FDA UDI e71a7803-2339-4af1-9fbf-58b844c97009 34 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced May 29, 2026