FDA.reportPublic FDA data

Safco Protect Ultra Flouride Varnish

Primary DI
00810063755270
Brand
Safco Protect Ultra Flouride Varnish
Company
SAFCO DENTAL SUPPLY CO.
Model
1028527
Catalog number
1028527
Device description
Safco Protect Ultra Flouride Varnish, caramel, 50/box
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
20810063755274PrimaryGS10
00810063755270Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081006375527420810063755274
00810063755270008100637552708100637552700810063755270

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizing, professionalA substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or 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., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020417380
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19
20810063756257Power Curve Toothbrush82500830022025-03-19
20810063756264Esprit Ultra Fine Toothbrush82500872082025-03-19
20810063756271Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
20810063756288Power Curve Toothbrush8250093002-I2025-03-19
20810063756400Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
20810063756431KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
20810063756585Jr Series Comfort Grip Toothbrush82500892402025-03-19
20810063756592Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063755564Waxed Dental Floss8250016300062025-03-18
20810063756172Euro Tech Compact Sensitive Toothbrush8250007T1872025-03-18
20810063756189Waxed Dental Floss8250017300072025-03-18
20810063756196Floss Picks8250039FP2025-03-18
20810063756202Endeavor Toothbrush8250043T0202025-03-18
20810063756219Vital Fresh Toothbrush8250048T056-I2025-03-18
20810063756226Aspire Compact Toothbrush8250060T509-I2025-03-18
20810063756233PlaquePRO Interdental Proxy Brush8250066T5132025-03-18
20810063756394Polisher Compact Toothbrush8250058T4902025-03-18
20810063756530Soft Flex Toothbrush8250054T183-I2025-03-18
20810063756547Glisten Junior Toothbrush8250064T511-I2025-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7714227200BG0Dental CityICP, INC.LBH2026-03-24
D7714227200M0Dental CityICP, INC.LBH2026-03-24
D7714227200ML0Dental CityICP, INC.LBH2026-03-24
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
00883205044068EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044075EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044082EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044099EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044105EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044112EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044129EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044136EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00858290006970FluoriMax 2.5% NaF demo pack ELEVATE ORAL CARE, LLCLBH2026-01-28
00827854027126Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
00827854027577Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
00883205044143EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044150EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044167EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044174EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00850006606719Wonderful DentalRoses and Rubies, LLCLBH2025-09-19
00850006606726Wonderful DentalRoses and Rubies, LLCLBH2025-09-19
00883205033000EnamelastULTRADENT PRODUCTS, INC.LBH2025-08-23
00883205032829ConsepsisULTRADENT PRODUCTS, INC.LBH2025-08-19
00883205032843ConsepsisULTRADENT PRODUCTS, INC.LBH2025-08-19
07615208545753Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10