FDA.reportPublic FDA data

VarnishAmerica

Primary DI
10310733000107
Brand
VarnishAmerica
Company
MEDICAL PRODUCTS LABORATORIES, INC.
Model
00010
Device description
Fluoride Varnish, Box of 200 single dose (0.25ml) mint
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
10310733000107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1031073300010710310733000107

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
10310733000114VarnishAmerica000112016-09-13
10310733000121VarnishAmerica000122016-09-13
10310733000138VarnishAmerica000132016-09-13
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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00850006606863Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
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