Identity
- Trade Name
- Immediate Implant FDA UDI
- Generic Name
- Basket endosteal dental implant, two-piece FDA UDI
- Device Name
- Ø6.0mm x L10.0mm, Conical Connection, Wide Platform FDA UDI
- Model / Reference
- IWC6010 FDA UDI
- Description
- Ø6.0mm x L10.0mm, Conical Connection, Wide Platform FDA UDI
Identifiers
- Primary DI / UDI-DI
- D824IWC60100 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
Single Use
Yes
Implantable
Yes
Contains Latex
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
Yes
Manufacturing Date
No
Category: Basket endosteal dental implant, two-piece
The Immediate Implant is a sterile, two-piece basket endosteal dental implant designed for surgical insertion into alveolar and/or basal bone of the mandible or maxilla to support and retain dental prostheses. Made from alloplastic materials such as titanium, stainless steel, or ceramic, this device provides a means of retention and support for various types of prosthesis.
Similar devices
Also classified as Basket endosteal dental implant, two-piece.
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- 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
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
- Surgikor, LLC
Sources (1)
- FDA UDI b156d9c7-4d8b-431d-9486-d8cc25500c67 34 fields · synced Jul 19, 2026