Identity
- Trade Name
- S-8 R EUDAMEDFDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Saw Handpieces OCI EUDAMEDMicro-Saw Handpiece reziprocal FDA UDI
- Model / Reference
- 10100801 EUDAMEDFDA UDI
- Description
- Micro-Saw Handpiece reziprocal FDA UDI
Identifiers
- Primary DI / UDI-DI
- +J021101008011 EUDAMEDJ021101008011 FDA UDI
- Basic UDI-DI
- ++J021S0009RJ EUDAMED
- Direct Marketing DI
- +J021101008010 EUDAMED
- FDA Product Code
- KMW FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental surgical power tool motorized handpiece/set, electric
S-8 R by W & H Dentalwerk Bürmoos GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- W & H Dentalwerk Bürmoos GmbH
Sources (2)
- FDA UDI 80b24eb6-9799-407c-b509-4f16c4490cfa 33 fields · synced Oct 7, 2026
- EUDAMED 14f0f055-dd36-49a6-977c-07a396396ecd 61 fields · synced Oct 7, 2026