Identity
- Trade Name
- Solution5 Implant FDA UDI
- Generic Name
- Basket endosteal dental implant, two-piece FDA UDI
- Device Name
- Ø3.25mm x L16.0mm, Conical Connection, Narrow Platform FDA UDI
- Model / Reference
- S5NC3216 FDA UDI
- Description
- Ø3.25mm x L16.0mm, Conical Connection, Narrow Platform FDA UDI
Identifiers
- Primary DI / UDI-DI
- D824S5NC32160 FDA UDI
- 510(k) Number
- K152555 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Basket 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basket endosteal dental implant, two-piece
Solution5 Implant by Surgikor, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basket endosteal dental implant, two-piece.
- MIS C1 — MIS Implants Technologies Ltd. · Class II
- DenQ Sub SLA Fixture I — Denq · Class II
- DenQ Sub SLA Fixture I — Denq · Class II
- DenQ Sub SLA Fixture II — Denq · Class II
- MIS SEVEN — MIS Implants Technologies Ltd. · Class II
- DenQ Sub SLA Fixture I — Denq · Class II
- DenQ Sub SLA Fixture II — Denq · Class II
- DenQ Sub SLA Fixture III — Denq · Class II
Cleared under the same submission
K152555 also covers:
- 15˚ Angled Anatomic Abutment — Surgikor, LLC
- 15˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 15˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 15˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 25˚ Angled Anatomic Abutment — Surgikor, LLC
- 25˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 25˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 25˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 25˚ Angled Non-Shouldered Abutment - Narrow Emergence — Surgikor, LLC
- Abutment short screw — Surgikor, LLC
- Anatomic Straight Abutment – Wide Emergence — Surgikor, LLC
- Anatomic Straight Abutment – Wide Emergence — Surgikor, 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
- Surgikor, LLC
Sources (1)
- FDA UDI 4569851d-ee58-4b9d-9ea5-183df3b4dfd9 34 fields · synced May 31, 2026