Identity
- Trade Name
- Inclusive® FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
- Device Name
- Inclusive® Guide Pin compatible with: Implant Direct® Legacy® Ø3.5/4.5/5.7 mm FDA UDI
- Model / Reference
- 70-1190-COM0032 FDA UDI
- Description
- Inclusive® Guide Pin compatible with: Implant Direct® Legacy® Ø3.5/4.5/5.7 mm FDA UDI
Identifiers
- Catalog Number
- 70-1190-COM0032 FDA UDI
- Primary DI / UDI-DI
- D745701190COM00320 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental prosthesis/implant abutment screw analog, reusable
Inclusive® by Prismatik Dentalcraft, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw analog, reusable.
- GS Convertible Pick-up Guide Pin — OSSTEM IMPLANT Co., Ltd. · Class I
- MEDENTiKA — Medentika GmbH · Class I
- Transfer Impression Coping — POINTIMPLANT Co., Ltd. · Class I
- One Stage TL Implant — I3 IMPLANT LLC · Class II
- infinity — ACE SURGICAL SUPPLY CO., INC. · Class I
- Bone Level Implant — I3 IMPLANT LLC · Class II
- MEDENTiKA — Medentika GmbH · Class I
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI 3b300546-c4aa-4962-86e6-62d8f816430d 34 fields · synced Jun 8, 2026