FDA.reportPublic FDA data

Ipana 5% Sodium Fluoride Varnish - Wintergreen

Primary DI
00060705405319
Brand
Ipana 5% Sodium Fluoride Varnish - Wintergreen
Company
MAXILL, INC.
Model
40531
Published
2016-09-19
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

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
00060705405319PrimaryGS10
90060705405312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00060705405319000607054053190607054053190060705405319
9006070540531290060705405312

GMDN Terms#

Term, Definition table
TermDefinition
Dental cavity varnishA liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius24 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079343581
Device count
48
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
D89260705601802PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601802024-01-12
D89260705601812PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601812024-01-12
D89260705601822PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601822024-01-12
D89260705601832PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601832024-01-12
D89260705601842PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601842024-01-12
D89260705601852PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601852024-01-12
D89260705601862PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601862024-01-12
D89260705601872PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601872024-01-12
D8926070553277D11maxill Frames Eyewear Adult6070553277D12022-11-15
D89260705532601maxill Frames Eyewear60705532602022-11-14
D89260705532631maxill Frames Eyewear60705532632022-11-14
D8926070553265D21maxill Frames Eyewear Kids6070553265D22022-11-14
D8926070553265D31maxill Frames Eyewear Kids6070553265D32022-11-14
D8926070553275C01maxill Frames Eyewear Adult6070553275C02022-11-14
D8926070553275C11maxill Frames Eyewear Adult6070553275C12022-11-14
D8926070553275C21maxill Frames Eyewear Adult6070553275C22022-11-14
D8926070553275C31maxill Frames Eyewear Adult6070553275C32022-11-14
D8926070553275C91maxill Frames Eyewear Adult6070553275C92022-11-14
D8926070553276C01maxill Frames Eyewear Adult6070553276C02022-11-14
D8926070553276C11maxill Frames Eyewear Adult6070553276C12022-11-14

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