Identity
- Trade Name
- J2A SLA Dental Implant System FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Model / Reference
- OTF5010RP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809488216055 FDA UDI
- 510(k) Number
- K161923 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Screw endosteal dental implant, two-piece
J2A SLA Dental Implant System by Kj Meditech — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K161923 also covers:
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2A SLA Dental Implant System — Kj Meditech
- J2C SLA Dental Implant System — Kj Meditech
- J2C SLA Dental Implant System — Kj Meditech
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
- Kj Meditech
Sources (1)
- FDA UDI a9a9c249-6e00-41c4-b984-91c1cc9f3de4 33 fields · synced Jun 8, 2026