Identity
- Trade Name
- BruxZir® FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 3.7/4.2 mm, C1 FDA UDI
- Model / Reference
- 70-1185-NOW0105 FDA UDI
- Description
- BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 3.7/4.2 mm, C1 FDA UDI
Identifiers
- Catalog Number
- 70-1185-NOW0105 FDA UDI
- Primary DI / UDI-DI
- D745701185NOW01050 FDA UDI
- 510(k) Number
- K231940 FDA UDI
- FDA Product Code
- PNP FDA UDINHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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 implant suprastructure, permanent, preformed
BruxZir® by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K231940 also covers:
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — PRISMATIK DENTALCRAFT, INC.
- BruxZir® — 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 ec629f81-0f09-46a7-896b-9f5641c81c90 35 fields · synced May 31, 2026