← Back to catalogue

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 porcelain/ceramic restoration kit FDA UDI
Model / Reference
MiYo Finishing System Kit FDA UDI

Identifiers

Catalog Number
MI990 FDA UDI
Primary DI / UDI-DI
00817340023121 FDA UDI
510(k) Number
K111743 FDA UDI
FDA Product Code
EIH FDA UDI
GMDN Term
Dental porcelain/ceramic restoration kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Commercial Distribution
Not 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

Yes

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

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

Cleared under the same submission

K111743 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Jensen Industries, Inc.

Sources (1)

  • FDA UDI 6b2456e4-fffd-41d4-bafd-7a7a9a750b39 35 fields · synced Jun 8, 2026