FDA.report

Safco Protect Ultra Flouride Varnish

Primary DI
00810063755300
Brand
Safco Protect Ultra Flouride Varnish
Company
SAFCO DENTAL SUPPLY CO.
Model
1028530
Catalog number
1028530
Device description
Safco Protect Ultra Flouride Varnish, bubble gum, 50/box
Published
2022-11-30
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

Related Records

Product Codes

CodeName
LBHVARNISH, CAVITY

Product Code Classifications

CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810063755304PrimaryGS10
00810063755300Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081006375530420810063755304
00810063755300008100637553008100637553000810063755300

GMDN Terms

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.

Sterilization Methods

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

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