Identity
- Trade Name
- PerFect TCS FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- 8 Sterilizable Electrodes and Cord Assembly FDA UDI
- Model / Reference
- S6000A FDA UDI
- Description
- 8 Sterilizable Electrodes and Cord Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661S6000A1 FDA UDI
- 510(k) Number
- K071632 FDA UDI
- FDA Product Code
- EKZ FDA UDI
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Electrosurgical system generator
PerFect TCS by Coltene/Whaledent Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071632 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI b8abf2b2-931b-48e0-89b9-22efbb360359 35 fields · synced Jun 9, 2026