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

Identifiers

Catalog Number
MI991 FDA UDI
Primary DI / UDI-DI
00817340023312 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

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Manufacturer

Manufacturer
Jensen Industries, Inc.

Sources (1)

  • FDA UDI d50c565e-9f20-493e-95d5-b081619b3b0c 35 fields · synced Jun 8, 2026