CAD/CAM Software

FDA UDI

Class II (US FDA UDI)

by Sirona Dental Systems GmbH

Identity

Trade Name: CAD/CAM Software FDA UDI
Generic Name: Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Device Name: inLab 16.0 Software FDA UDI
Model / Reference: 6610427 FDA UDI
Description: inLab 16.0 Software FDA UDI

Identifiers

Primary DI / UDI-DI: E27666104270 FDA UDI
510(k) Number: K100152 FDA UDI
K111421 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant abutment analog, intraoral-scanning, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 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

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

FDA UDI

Category: Dental implant abutment analog, intraoral-scanning, single-use

CAD/CAM Software by Sirona Dental Systems GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Sirona Dental Systems GmbH

Sources (1)

FDA UDI 0be0dd6b-abe5-44c4-adbc-d5ca87f17643 35 fields · synced Jun 1, 2026

CAD/CAM Software

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)