← Back to catalogue

Regennex-Bioactive Universal Bond Refill Kit

FDA UDI

Class II (US FDA UDI)

by Vista Dental

Identity

Trade Name
Regennex-Bioactive Universal Bond Refill Kit FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Model / Reference
90638-2 FDA UDI

Identifiers

Primary DI / UDI-DI
10818207020540 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

Regennex-Bioactive Universal Bond Refill Kit by Vista Dental — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vista Dental

Sources (1)

  • FDA UDI 52b80c2c-8ddf-469e-bca4-79ec60825431 34 fields · synced Jun 1, 2026