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Beautibond Xtreme

FDA UDI

Class II (US FDA UDI)

by Shofu Dental Corp.

Identity

Trade Name
BEAUTIBOND XTREME FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
BEAUTIBOND XTREME 2ML BOTTLE SAMPLE FDA UDI
Model / Reference
Y2704 FDA UDI
Description
BEAUTIBOND XTREME 2ML BOTTLE SAMPLE FDA UDI

Identifiers

Catalog Number
Y2704 FDA UDI
Primary DI / UDI-DI
04548162305084 FDA UDI
510(k) Number
K213965 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 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

Yes

FDA UDI

Category: Dentine bonding agent/set

Beautibond Xtreme by Shofu Dental Corp. — 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

K213965 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shofu Dental Corp.

Sources (1)

  • FDA UDI ecceee49-c3e9-412a-9160-e2e007a866eb 37 fields · synced Jun 6, 2026