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Schick

FDA UDI

Class I (US FDA UDI)

by Sirona Dental, Inc.

Identity

Trade Name
SCHICK FDA UDI
Generic Name
Diagnostic-imaging photographic film, self-developing FDA UDI
Device Name
USB CAM4 FDA UDI
Model / Reference
B6306100 FDA UDI
Description
USB CAM4 FDA UDI

Identifiers

Primary DI / UDI-DI
D764B63061000 FDA UDI
510(k) Number
K963778 FDA UDI
FDA Product Code
EIA FDA UDI
GMDN Term
Diagnostic-imaging photographic film, self-developing FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic-imaging photographic film, self-developing

Schick by Sirona Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic-imaging photographic film, self-developing.

Cleared under the same submission

K963778 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sirona Dental, Inc.

Sources (1)

  • FDA UDI 80bbfdf1-6ec4-41f3-813f-9912871b9524 35 fields · synced May 30, 2026