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OrangeCAD Med

FDA UDI

Class I (US FDA UDI)

by OrangeCAD MED GmbH

Identity

Trade Name
OrangeCAD Med FDA UDI
Generic Name
Dental implant abutment analog, laboratory FDA UDI
Device Name
Laboratory implant FDA UDI
Model / Reference
SMTL2401H FDA UDI
Description
Laboratory implant FDA UDI

Identifiers

Catalog Number
SMTL2401H FDA UDI
Primary DI / UDI-DI
04262365194497 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant abutment analog, laboratory 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Dental implant abutment analog, laboratory

OrangeCAD Med by OrangeCAD MED GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant abutment analog, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OrangeCAD MED GmbH

Sources (1)

  • FDA UDI 4701e32b-e664-47b5-a356-fb1cfd30b061 35 fields · synced Jun 8, 2026