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FDA UDI

Class I (US FDA UDI)

by Ace Surgical Supply Co., Inc.

Identity

Trade Name
infinity FDA UDI
Generic Name
Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Device Name
RP Contoured Closed Tray Impression Post, D 4.5 mm, H 11.9 mm FDA UDI
Model / Reference
1312678 FDA UDI
Description
RP Contoured Closed Tray Impression Post, D 4.5 mm, H 11.9 mm FDA UDI

Identifiers

Catalog Number
1312678 FDA UDI
Primary DI / UDI-DI
00614950025794 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental prosthesis/implant abutment screw analog, reusable 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

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental prosthesis/implant abutment screw analog, reusable

infinity by Ace Surgical Supply Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental prosthesis/implant abutment screw analog, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ace Surgical Supply Co., Inc.

Sources (1)

  • FDA UDI 826cb29a-b818-4e6f-93d6-9d81abf95bf6 35 fields · synced May 30, 2026