Glidewell IH™

FDA UDI

Class I (US FDA UDI)

by Prismatik Dentalcraft, Inc.

Identity

Trade Name: Glidewell IH™ FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: Glidewell IH™ Screw Tap Ø4.2 mm FDA UDI
Model / Reference: 70-1071-SRG0441 FDA UDI
Description: Glidewell IH™ Screw Tap Ø4.2 mm FDA UDI

Identifiers

Catalog Number: 70-1071-SRG0441 FDA UDI
Primary DI / UDI-DI: D745701071SRG04410 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

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

Glidewell IH™ by Prismatik Dentalcraft, Inc. — 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: Prismatik Dentalcraft, Inc.

Sources (1)

FDA UDI f0d93ec0-5dd5-4c3a-8089-b2d0d714e496 34 fields · synced Jun 8, 2026