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Citrine

FDA UDI

Class II (US FDA UDI)

by Dharma Research, Inc.

Identity

Trade Name
Citrine FDA UDI
Generic Name
Dental coating, tooth-desensitizing, professional FDA UDI
Device Name
Citrine 5% Sodium Fluoride Varnish, Spearmint Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brushes, 1 Doctor Instruction Insert and 50 Patient Instruction Inserts FDA UDI
Model / Reference
56-00200 FDA UDI
Description
Citrine 5% Sodium Fluoride Varnish, Spearmint Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brushes, 1 Doctor Instruction Insert and 50 Patient Instruction Inserts FDA UDI

Identifiers

Catalog Number
56-00200 FDA UDI
Primary DI / UDI-DI
00353045002349 FDA UDI
FDA Product Code
LBH 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

No

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

Dimensions & Sizes

Size
Total Volume — 0.4 Milliliter FDA UDI

Category: Dental coating, tooth-desensitizing, professional

Citrine by Dharma Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dharma Research, Inc.

Sources (1)

  • FDA UDI 5c77e7f8-97e5-4ad6-af6c-25f5b7e2c9a1 37 fields · synced May 30, 2026