← Back to catalogue

Infinix Universal Bond - Primer

FDA UDI

Class II (US FDA UDI)

by Nobio Ltd

Identity

Trade Name
Infinix Universal Bond - Primer FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Universal Bond- Primer 2.5ml for starter kit FDA UDI
Model / Reference
INF-PR-PP-MD2.5ML FDA UDI
Description
Universal Bond- Primer 2.5ml for starter kit FDA UDI

Identifiers

Primary DI / UDI-DI
07290017528335 FDA UDI
510(k) Number
K183391 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

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: Dentine bonding agent/set

Infinix Universal Bond - Primer by Nobio Ltd — 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

K183391 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
Nobio Ltd

Sources (1)

  • FDA UDI 60dd7581-c523-46aa-aee8-983e9f6b89cd 34 fields · synced May 30, 2026