Identity
- Trade Name
- RePlant Complete Surgical Tray FDA UDI
- Generic Name
- Dental implant/prosthesis surgical procedure kit FDA UDI
- Model / Reference
- RCST FDA UDI
Identifiers
- Catalog Number
- RCST FDA UDI
- Primary DI / UDI-DI
- 10841307117575 FDA UDI
- 510(k) Number
- K142519 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Dental implant/prosthesis surgical procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant/prosthesis surgical procedure kit
RePlant Complete Surgical Tray by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant/prosthesis surgical procedure kit.
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- SELF THREAD/LOGIC PLUS/SPARK — Hi-Tec Implants · Class II
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Cleared under the same submission
K142519 also covers:
- Basic Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Complete Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- InterActive® Basic Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- InterActive® Complete Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- InterActive® Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- RePlant Basic Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- RePlant Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Swish™ Basic Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Swish™ Complete Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Swish™ Surgical Tray — IMPLANT DIRECT SYBRON MANUFACTURING LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implant Direct Sybron Manufacturing Llc
Sources (1)
- FDA UDI 9a08047c-6b32-4c35-8b4f-aa4a713bf59c 35 fields · synced Jun 8, 2026