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 CAM 16.0 Software FDA UDI
Model / Reference: 6610161 FDA UDI
Description: inLab CAM 16.0 Software FDA UDI

Identifiers

Primary DI / UDI-DI: E27666101610 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

SET ZZ BASE NB-Z-WSM B4.1 — Zirkonzahn GmbH · Class I
DIO Zimmer Scan Adapter — DIO Corporation · Class I
Zirlux — HENRY SCHEIN, INC. · Class I
Preat Implant Prosthetics — PREAT Corporation · Class I
TruScan body — Truabutment Korea Co., Ltd · Class I
DIRECTscan™ Adapter Single Wing-A — APOLLO IMPLANT COMPONENTS SP Z O O · Class I
Azure — TERRATS MEDICAL SL. · Class I
SET ZZ BASE C-J-WSM 4.3 — Zirkonzahn GmbH · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sirona Dental Systems GmbH

Sources (1)

FDA UDI 3ba1d0d8-fa69-4fa8-b0f4-f54ef3d29fb6 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)