Surgical Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- KIT SURGICAL GUIDED STRONG SW EUDAMEDSURGICAL KIT FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- KIT SURGICAL GUIDED STRONG SW EUDAMEDGUIDED SURGERY KIT STRONG SW FDA UDI
- Model / Reference
- KCSWG 04 EUDAMEDFDA UDISURGICAL KIT EUDAMED
- Description
- GUIDED SURGERY KIT STRONG SW FDA UDI
Identifiers
- Catalog Number
- KCSWG 04 FDA UDI
- Primary DI / UDI-DI
- 07899995299918 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000075KD EUDAMED
- 510(k) Number
- K201688 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Surgical Kit by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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Cleared under the same submission
K201688 also covers:
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI 9a5acec4-e4cc-4ac4-b531-e5300c0d8d25 35 fields · synced Jul 25, 2026
- EUDAMED 2f06caf7-6119-4ea9-b983-9351acd2b4b6 61 fields · synced Jul 25, 2026