FDA.reportPublic FDA data

VarnishAmerica

Primary DI
10310733000138
Brand
VarnishAmerica
Company
MEDICAL PRODUCTS LABORATORIES, INC.
Model
00013
Device description
Fluoride Varnish, Box of 32 single dose (0.4ml) white bubble gum
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10310733000138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1031073300013810310733000138

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
215-677-2700sneunuebel@mplusa.com

Regulatory Flags#

DUNS number
002290302
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10310733000077VarnishAmerica000072016-09-13
10310733000084VarnishAmerica000082016-09-13
10310733000107VarnishAmerica000102016-09-13
10310733000114VarnishAmerica000112016-09-13
10310733000121VarnishAmerica000122016-09-13
10310733000152VarnishAmerica000152016-09-13
10310733000169VarnishAmerica000162016-09-13
10310733000176VarnishAmerica000172016-09-13
10310733000183VarnishAmerica000182016-09-13
10310733000190VarnishAmerica000192016-09-13
10310733000206VarnishAmerica000202016-09-13
10310733000213VarnishAmerica000212016-09-13
10310733000220VarnishAmerica000222016-09-13
10310733000312VarnishAmerica000312016-09-13
10310733000329VarnishAmerica000322016-09-13
13010733000145VarnishAmerica000142016-09-13
10310733000015VarnishAmerica000012016-09-09
10310733000022VarnishAmerica000022016-09-09
10310733000039VarnishAmerica000032016-09-13
10310733000046VarnishAmerica000042016-09-13

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00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
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00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
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