Identity
- Trade Name
- PerFect TCS Footswitch EUDAMEDPerFect TCS FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- PerFect TCS II EUDAMEDTissue Contouring System Footswitch FDA UDI
- Model / Reference
- S8FSRK EUDAMEDFDA UDI
- Description
- Tissue Contouring System Footswitch FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661S8FSRK0 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661S8FSRK0 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 Footswitch 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-D661S8FSRK0 | 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 5ee0bde9-5cc9-4ab3-a7e6-04f9511f1426 61 fields · synced Jul 17, 2026
- FDA UDI 1ad27563-1087-45fa-94a0-79b76e39fbc7 35 fields · synced May 29, 2026