Power Dental U.S.A., Inc.

FDA UDI

Class I (US FDA UDI)

by Power Dental USA, Inc.

Identity

Trade Name: Power Dental U.S.A., Inc. FDA UDI
Generic Name: Scalpel handle, reusable FDA UDI
Device Name: BLUE TITANIUM SCALPEL HANDLE FDA UDI
Model / Reference: N6920BT FDA UDI
Description: BLUE TITANIUM SCALPEL HANDLE FDA UDI

Identifiers

Catalog Number: N6920BT FDA UDI
Primary DI / UDI-DI: D943N6920BT00 FDA UDI
FDA Product Code: GDZ FDA UDI
GMDN Term: Scalpel handle, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Scalpel handle, reusable

Power Dental U.S.A., Inc. by Power Dental USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Scalpel handle, reusable.

HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
KNIFE HANDLE — SONTEC INSTRUMENTS, INC. · Class I
SCALPEL HANDLE #4 — W.H. Holden, Inc. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Power Dental USA, Inc.

Sources (1)

FDA UDI 8f2888c1-6128-4013-a368-07628ae18b9c 35 fields · synced Jun 1, 2026