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SilverSense

FDA UDI

Class II (US FDA UDI)

by Centrix, Inc.

Identity

Trade Name
SilverSense FDA UDI
Generic Name
Dental coating, tooth-desensitizing, professional FDA UDI
Device Name
SilverSense Standard Kit FDA UDI
Model / Reference
310172 FDA UDI
Description
SilverSense Standard Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00817051023632 FDA UDI
510(k) Number
K222459 FDA UDI
FDA Product Code
PHR FDA UDI
GMDN Term
Dental coating, tooth-desensitizing, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3260 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

Yes

FDA UDI

Category: Dental coating, tooth-desensitizing, professional

A comprehensive dental coating designed to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents.

Similar devices

Also classified as Dental coating, tooth-desensitizing, professional.

Cleared under the same submission

K222459 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Centrix, Inc.

Sources (1)

  • FDA UDI 68bc2748-8a34-4d3f-b30f-246e202b6c67 34 fields · synced Jul 24, 2026