FDA.report

3D Dental-Dream

Primary DI
00817169021476
Brand
3D Dental-Dream
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
DFVCM
Device description
DREAM FLUORIDE VARNISH CARAMEL..40 ML BOX/50
Published
2017-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LBHVarnish, Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10817169021473PackageGS1600In Commercial Distribution
00817169021476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081716902147310817169021473
00817169021476008171690214768171690214760817169021476

GMDN Terms

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

Contacts

PhoneEmail
877-605-8061cs@3d-dent.com

Regulatory Flags

DUNS number
080194935
Device count
1
DM exempt
true
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

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10817169023019Basik by 3D DentalBPGLA4672026-03-17
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008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
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008101265081953D DentalJSM-W2026-03-16
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00810126508218Essentials By 3D DentalPBBT-1002026-03-11
00810126508225Essentials By 3D DentalPBBT-202026-03-11
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00810126508256Basik by 3D DentalBPGC304T2026-03-11
00810126508263Basik by 3D DentalBPGC303T2026-03-11

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