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Infinity External Hex Implant System

FDA UDI

Class II (US FDA UDI)

by Ace Surgical Supply Co., Inc.

Identity

Trade Name
Infinity External Hex Implant System FDA UDI
Generic Name
Dental restoration retention pin FDA UDI
Device Name
IMPRESSION COPING Ø6.0MM UNI-TORX GUIDE PINS GREEN [NOBLEBIOCARE] FDA UDI
Model / Reference
54600097 FDA UDI
Description
IMPRESSION COPING Ø6.0MM UNI-TORX GUIDE PINS GREEN [NOBLEBIOCARE] FDA UDI

Identifiers

Catalog Number
54600097 FDA UDI
Primary DI / UDI-DI
00614950007035 FDA UDI
510(k) Number
K954513 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental restoration retention pin 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

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 6 Millimeter FDA UDI

Category: Dental restoration retention pin

Infinity External Hex Implant System by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental restoration retention pin.

Cleared under the same submission

K954513 also covers:

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 65208637-234f-4237-9cdd-18a9ddc863ed 37 fields · synced Jun 8, 2026