FDA.reportPublic FDA data

Burkhart Varnish 5% NaF Mint 0.4mL (50)

Primary DI
00854212006783
Brand
Burkhart Varnish 5% NaF Mint 0.4mL (50)
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72722203
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854212006783PrimaryGS10
00854212006820Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854212006783008542120067838542120067830854212006783
00854212006820008542120068208542120068200854212006820

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)562-8176customerservice@burkhartdental.com

Regulatory Flags#

DUNS number
027532357
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815878028397Burkhart Dental Supply727209812024-12-06
00815878028403Burkhart Dental Supply727209822024-12-06
00815878028410Burkhart Dental Supply727209832024-12-06
00815878028427Burkhart Dental Supply727209842024-12-06
00815878027628Burkhart Dental Supply727220272024-05-07
00815878027642Burkhart Dental Supply727220292024-05-07
00810052614458Burkhart Dental Supply727218522024-01-26
00810052614557Burkhart Dental Supply727218502024-01-26
00810052614564Burkhart Dental Supply727218482024-01-26
00810052615042Burkhart Dental Supply727218542024-01-26
00810052615899Burkhart Dental Supply727218552024-01-26
00810052616780Burkhart Dental Supply727218562024-01-26
00810052617770Burkhart Dental Supply727219622024-01-26
00810052618883Burkhart Dental Supply727219632024-01-26
00810052619873Burkhart Dental Supply727218572024-01-26
00810052619996Burkhart Dental Supply727219642024-01-26
00810052610306Burkhart Dental Supply727218402024-01-15
00810052610313Burkhart Dental Supply727218412024-01-15
00810052610320Burkhart Dental Supply727218422024-01-15
00810052610337Burkhart Dental Supply727218432024-01-15

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D771422750ML0Dental CityICP, INC.LBH2026-03-24
G402DENTOCLUDE1Dentoclude FCUMBERLAND BIOTHERAPEUTICS LLCLBH2026-03-19
09336472038212RIVA STARSDI LIMITEDLBH2026-02-16
09336472038366RIVA STAR AQUASDI LIMITEDLBH2026-02-16
09336472038403RIVA STAR AQUASDI LIMITEDLBH2026-02-16
09336472038441RIVA STARSDI LIMITEDLBH2026-02-16
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00883205044136EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
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