Identity
- Trade Name
- Inclusive® FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- Inclusive Titanium Screw compatible with: Keystone® Dental PrimaConnex® SD/RD/WD FDA UDI
- Model / Reference
- 70-1055-COM0072 FDA UDI
- Description
- Inclusive Titanium Screw compatible with: Keystone® Dental PrimaConnex® SD/RD/WD FDA UDI
Identifiers
- Catalog Number
- 70-1055-COM0072 FDA UDI
- Primary DI / UDI-DI
- D745701055COM00720 FDA UDI
- 510(k) Number
- K240240 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental prosthesis/implant abutment screw
Inclusive® by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
- Recharge Kit w/ POC, TiLobe — SMART DENTURE CONVERSIONS, LLC · Class I
Cleared under the same submission
K240240 also covers:
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
- Inclusive® — PRISMATIK DENTALCRAFT, INC.
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 |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI f7f393c4-7361-4daf-b75a-dacd938a4a25 35 fields · synced Jun 1, 2026