FDA.report

ACRYLIC PRIMER LIQUID

Primary DI
D6501608P0
Brand
ACRYLIC PRIMER LIQUID
Company
LANG DENTAL MANUFACTURING CO., INC.
Model
19 L
Catalog number
1608P
Device description
BONDING ENHANCER
Published
2016-09-01
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

Related Records

Product Codes

CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6501608P0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Sterilization Methods

Method

Regulatory Flags

DUNS number
005185798
Device count
1
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

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D6504730F20JET SET-4 DENTURE REPAIR454 GRAM F24730F22022-10-20
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D6504734P10JET SET-4 DENTURE REPAIRPOUND PACKAGE P14734P12022-10-20
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