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Estecem Ii

FDA UDI

Class II (US FDA UDI)

by Tokuyama Dental Corporation

Identity

Trade Name
ESTECEM II FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
KIT UNIVERSAL FDA UDI
Model / Reference
16148 FDA UDI
Description
KIT UNIVERSAL FDA UDI

Identifiers

Primary DI / UDI-DI
04548190161485 FDA UDI
510(k) Number
K150727 FDA UDI
K171226 FDA UDI
FDA Product Code
KLE FDA UDI
EMA FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 FDA UDI
872.3275 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental composite resinDentine bonding agent/set

Estecem Ii by Tokuyama Dental Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Cleared under the same submission

K150727 also covers:

K171226 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tokuyama Dental Corporation

Sources (1)

  • FDA UDI b80c0ff7-b876-4c7d-9aed-19af34f14cad 36 fields · synced May 29, 2026