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Brush&Bond®

FDA UDI

Class II (US FDA UDI)

by Parkell, Inc.

Identity

Trade Name
Brush&Bond® FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Brush&Bond® Standard Activator Brushes (Pkg. of 100 pcs.) FDA UDI
Model / Reference
S286 FDA UDI
Description
Brush&Bond® Standard Activator Brushes (Pkg. of 100 pcs.) FDA UDI

Identifiers

Catalog Number
S286 FDA UDI
Primary DI / UDI-DI
10810000529138 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dentine bonding agent/set

Brush&Bond® by Parkell, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Parkell, Inc.

Sources (1)

  • FDA UDI a64b8094-dd46-474e-8f8d-a2e2209c11c1 36 fields · synced Jun 1, 2026