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POLISHING AND FINISHING POLYESTER STRIPS 4, 0mm box w/150
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10.302.005
Identity
- Trade Name
- POLISHING AND FINISHING POLYESTER STRIPS 4,0mm box w/150 EUDAMEDMicrodont FDA UDI
- Generic Name
- Dental abrasive strip, single-use FDA UDI
- Device Name
- DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMEDAbrasive Polyester Strip for Polishing and Finishing - 4,0mm - Box w/150 pcs FDA UDI
- Model / Reference
- 10.302.005 EUDAMEDFDA UDI
- Description
- Abrasive Polyester Strip for Polishing and Finishing - 4,0mm - Box w/150 pcs FDA UDI
Identifiers
- Catalog Number
- 10.302.005 FDA UDI
- Primary DI / UDI-DI
- 07898229800708 EUDAMEDFDA UDI
- Basic UDI-DI
- 79085168stripsB2 EUDAMED
- FDA Product Code
- EHM FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive strip, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
POLISHING AND FINISHING POLYESTER STRIPS 4, 0mm box w/150 by 3R Indústria E Comércio LTDA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 79085168stripsB2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3R Indústria E Comércio LTDA
- EUDAMED SRN
- BR-MF-000034808
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED bb973f5e-0d0c-4bd5-ad73-96a2cbcd0502 61 fields · synced Jul 15, 2026
- FDA UDI 1768c297-3015-451f-a888-92d40d927eab 34 fields · synced May 25, 2026