Dio Protem Implant Systems

FDA UDI

Class I (US FDA UDI)

by DIO Corporation

Identity

Trade Name: DIO PROTEM IMPLANT SYSTEMS FDA UDI
Generic Name: Dental implant analog FDA UDI
Device Name: The DIO Protem Implant System consist of Dental Implant, Superstructure, Prosthetics and Surgical Instruments. The Protem Implants is an integrated system of endosseous dental implants which increas indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implant which provide the clinician to maintain the patients` gingival contour. The Implants have the diameter(2.0/2.5mm) and length(8/10/12/14mm). The superstructures consist of Ball Cap. Ball Cap intended to retain the O-ring inside of the denture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The Implants are gamma sterilized and intended to single use. And the others and non-gamma stereilized and have to be sterilized by user before using. FDA UDI
Model / Reference: MAB 2510 FDA UDI
Description: The DIO Protem Implant System consist of Dental Implant, Superstructure, Prosthetics and Surgical Instruments. The Protem Implants is an integrated system of endosseous dental implants which increas indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implant which provide the clinician to maintain the patients` gingival contour. The Implants have the diameter(2.0/2.5mm) and length(8/10/12/14mm). The superstructures consist of Ball Cap. Ball Cap intended to retain the O-ring inside of the denture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The Implants are gamma sterilized and intended to single use. And the others and non-gamma stereilized and have to be sterilized by user before using. FDA UDI

Identifiers

Catalog Number: MAB 2510 FDA UDI
Primary DI / UDI-DI: 08800049273494 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental implant analog 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

Yes

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

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 analog

Dio Protem Implant Systems by DIO Corporation — 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: DIO Corporation

Sources (1)

FDA UDI b7c39a5b-4c08-4494-8420-850339fbc580 37 fields · synced May 29, 2026