Identity
- Trade Name
- Inclusive FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Inclusive Analog, Solid Abutment 14.3 mmL compatible with: Straumann Tissue Level RN synOcta FDA UDI
- Model / Reference
- 70-1053-COM0019 FDA UDI
- Description
- Inclusive Analog, Solid Abutment 14.3 mmL compatible with: Straumann Tissue Level RN synOcta FDA UDI
Identifiers
- Catalog Number
- 70-1053-COM0019 FDA UDI
- Primary DI / UDI-DI
- D745701053COM00190 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant analog 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
Dimensions & Sizes
- Size
- Height — 14.3 Millimeter FDA UDI
Category: Dental implant analog
Inclusive by Prismatik Dentalcraft, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · 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 |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI 6063faea-4c4e-4c6b-9e74-d9a2bb5b0169 36 fields · synced Jun 8, 2026