PUR® 3.2mm Tap

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: PUR® 3.2mm Tap FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: A metal device intended to be used to create internal threads in surgical site for implants. They are available in narrow and regular platforms and different sizes. FDA UDI
Model / Reference: 905256 FDA UDI
Description: A metal device intended to be used to create internal threads in surgical site for implants. They are available in narrow and regular platforms and different sizes. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549114748 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Bone tap, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone tap, reusable

PUR® 3.2mm Tap by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Sterngold Dental LLC

Sources (1)

FDA UDI ec1a9223-a656-4314-b5f4-1d7de39aa97d 34 fields · synced May 31, 2026