Identity
- Trade Name
- Inclusive FDA UDI
- Generic Name
- Dental impression spacer FDA UDI
- Device Name
- Inclusive Mini Implant Blockout Shims (25-Pack) FDA UDI
- Model / Reference
- 70-1066-MNI0001 FDA UDI
- Description
- Inclusive Mini Implant Blockout Shims (25-Pack) FDA UDI
Identifiers
- Catalog Number
- 70-1066-MNI0001 FDA UDI
- Primary DI / UDI-DI
- D745701066MNI00011 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental impression spacer 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
- Outer Diameter — 3.2 Millimeter FDA UDI
Category: Dental impression spacer
Inclusive by Prismatik Dentalcraft, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression spacer.
- COE TRAY PLASTIC™ — Gc America Inc. · Class I
- Preat — PREAT Corporation · Class I
- COE TRAY PLASTIC™ — Gc America Inc. · Class I
- COE TRAY PLASTIC™ — Gc America Inc. · Class I
- LOCATOR R-Tx — Zest Anchors, LLC · Class I
- LOCATOR® — Zest Anchors, LLC · Class I
- COE TRAY PLASTIC™ — Gc America Inc. · Class I
- GC OCCLUSAL MATRIX SYSTEM — Gc America 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 f89a847f-e2c1-40a4-a777-ca19dc780871 36 fields · synced May 30, 2026