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Hahn

FDA UDI

Class II (US FDA UDI)

by Prismatik Dentalcraft, Inc.

Identity

Trade Name
Hahn FDA UDI
Generic Name
Dental prosthesis/implant abutment screw FDA UDI
Device Name
Hahn Tapered Implant Titanium Screw - Ø3.5/4.3 Implant (5-pack) FDA UDI
Model / Reference
70-1153-PRC0005 FDA UDI
Description
Hahn Tapered Implant Titanium Screw - Ø3.5/4.3 Implant (5-pack) FDA UDI

Identifiers

Catalog Number
70-1153-PRC0005 FDA UDI
Primary DI / UDI-DI
D745701153PRC00050 FDA UDI
510(k) Number
K143353 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
Not 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Height — 7.3 Millimeter FDA UDI

Hahn by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K143353 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Prismatik Dentalcraft, Inc.

Sources (1)

  • FDA UDI 86b7981a-770d-4d99-aa83-035cd5c237d9 38 fields · synced May 31, 2026