Identity
- Trade Name
- PerFect TCS Handpiece Holder EUDAMEDPerFect TCS FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- PerFect TCS II EUDAMEDHand Piece Holder FDA UDI
- Model / Reference
- S7001 EUDAMEDFDA UDI
- Description
- Hand Piece Holder FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661S70010 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661S70010 EUDAMED
- 510(k) Number
- K071632 FDA UDI
- FDA Product Code
- EKZ FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4920 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PerFect TCS Handpiece Holder by Coltene/Whaledent Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661S70010 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED f80ee3a2-012e-4478-be14-c72e3a01c177 61 fields · synced Aug 3, 2026
- FDA UDI 47c03a18-dd20-4275-80fc-70bd87375157 35 fields · synced May 30, 2026