Identity
- Trade Name
- Hahn FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Hahn Tapered Implant Healing Abutment 5 mmH - Ø3.5 Implant FDA UDI
- Model / Reference
- 70-1153-IMP0005 FDA UDI
- Description
- Hahn Tapered Implant Healing Abutment 5 mmH - Ø3.5 Implant FDA UDI
Identifiers
- Catalog Number
- 70-1153-IMP0005 FDA UDI
- Primary DI / UDI-DI
- D745701153IMP00050 FDA UDI
- 510(k) Number
- K143353 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Hahn by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Cleared under the same submission
K143353 also covers:
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC.
- Glidewell HT™ — 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 a2c16f86-fde3-4538-a32a-cd626cfae90e 37 fields · synced May 30, 2026