Identity
- Trade Name
- FitStrip™ Interproximal Finishing & Contouring EUDAMEDFitStrip™ FDA UDI
- Generic Name
- Dental abrasive strip, single-use FDA UDI
- Device Name
- Polishers & Abrasives Family EUDAMEDSingle-Sided, Super Fine Grit, Yellow FDA UDI
- Model / Reference
- FPSXFSS-1 EUDAMEDFDA UDI
- Description
- Single-Sided, Super Fine Grit, Yellow FDA UDI
Identifiers
- Catalog Number
- FPSXFSS-1 FDA UDI
- Primary DI / UDI-DI
- 00810038094168 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809PolishersTFAC EUDAMED
- FDA Product Code
- DZP 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
- 872.4535 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive strip, single-use
FitStrip™ by Garrison Dental Solutions, L.l.c. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Garrison Dental Solutions, L.l.c.
Sources (2)
- FDA UDI fd8d98d6-07ed-465e-8737-0b8ce6c62321 35 fields · synced Jul 15, 2026
- EUDAMED e710296f-e2fb-4150-b83a-871964ff7f83 61 fields · synced Jul 15, 2026