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InSync Ceramic System

FDA UDI

Class II (US FDA UDI)

by Jensen Industries, Inc.

Identity

Trade Name
InSync Ceramic System FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Model / Reference
InSync Glaze / Stain Liquid 25ml FDA UDI

Identifiers

Catalog Number
0800 FDA UDI
Primary DI / UDI-DI
00817340025781 FDA UDI
510(k) Number
K111743 FDA UDI
FDA Product Code
EIH FDA UDI
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6660 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

InSync Ceramic System by Jensen Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Cleared under the same submission

K111743 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jensen Industries, Inc.

Sources (1)

  • FDA UDI 09c2da76-fbd5-4b9c-80f5-d5185a25c742 34 fields · synced May 30, 2026