DIOnavi-SG

FDA UDI

Class I (US FDA UDI)

by DIO Corporation

Identity

Trade Name: DIOnavi-SG FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Model / Reference: 3DSG-1000 FDA UDI

Identifiers

Primary DI / UDI-DI: 08806169098122 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental appliance fabrication material, resin 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, resin

DIOnavi-SG by DIO Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, resin.

O-Cryl Self Curing Acrylic Shade White X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
PREMIUM — Lang Dental Manufacturing Company, Inc. · Class II
Axcent Acrylics — GARRECO, LLC · Class II
smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
HI-I® — FRICKE INTERNATIONAL, INC. · Class II
FREEPRINT crown A1 500g — DETAX GmbH · Class II

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 51205333-6ee2-459e-b018-c6cc88b09745 32 fields · synced May 31, 2026