Protem Stopper Holder(4mm)

FDA UDI

Class I (US FDA UDI)

by DIO Corporation

Identity

Trade Name: Protem Stopper Holder(4mm) FDA UDI
Generic Name: Dental implant/prosthesis handling forceps FDA UDI
Model / Reference: PSH 04 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800049457030 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental implant/prosthesis handling forceps 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: Dental implant/prosthesis handling forceps

Protem Stopper Holder(4mm) by DIO Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant/prosthesis handling forceps.

Power Dental USA — Power Dental USA, Inc. · Class I
Paul Banditt — Terlain Enterprises, Inc. · Class I
Power Dental USA — Power Dental USA, Inc. · Class I
Laschal Surgical — LASCHAL SURGICAL Instruments, LLC · Class I
Smileloc® BY RODO — RODO MEDICAL, INC · Class I
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
KOHDENT — Kohler Medizintechnik GmbH & Co. KG · 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: DIO Corporation

Sources (1)

FDA UDI 13839f3d-0668-4004-9012-2f8e214d43aa 32 fields · synced May 30, 2026