FDA.report

PermaLiner

Primary DI
D814SIL221
Brand
PermaLiner
Company
PROTECH PROFESSIONAL PRODUCTS INC
Model
SILL2
Device description
PermaLiner 70g heat cure silicone soft reline
Published
2017-12-22
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
false

Related Records

Product Codes

CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D814SIL221PrimaryHIBCC0

GMDN Terms

TermDefinition
Denture reliner, elastic, short-termA denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117374900
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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D814UBARV11GD0ProTech UBARUBARV11GDUBARV11GD2019-10-30
D814PLUS12AC0ProTech Plus Hard Reline and Repair AcrylicPLUS12ACPLUS12AC2019-09-24
D814PLUS12AD0ProTech Plus Hard Reline and Repair AcrylicPLUS12ADPLUS12AD2019-09-24
D814PLUS12GC0ProTech Plus Hard Reline and Repair AcrylicPLUS12GCPLUS12GC2019-09-24
D814PLUS12GD0ProTech Plus Hard Reline and Repair AcrylicPLUS12GDPLUS12GD2019-09-24
D814PLUS13GC0ProTech Plus Hard Reline and Repair AcrylicPLUS13GCPLUS13GC2019-09-24
D814PLUS13GD0ProTech Plus Hard Reline and Repair AcrylicPLUS13GDPLUS13GD2019-09-24
D814UBAR11AC0ProTech UBARUBAR11ACUBAR11AC2019-09-24
D814UBAR11AD0ProTech UBARUBAR11ADUBAR11AD2019-09-24
D814UBAR11GC0ProTech UBARUBAR11GCUBAR11GC2019-09-24
D814UBAR11GD0ProTech UBARUBAR11GDUBAR11GD2019-09-24
D814UBAR590ProTech UBARUBAR59UBAR592019-08-02
D814UBAR59A0ProTech UBARUBAR59AUBAR59A2019-08-02
D814UBAR59B0ProTech UBARUBAR59BUBAR59B2019-08-02
D814UBAR59C0ProTech UBARUBAR59CUBAR59C2019-08-02
D814UBAR59D0ProTech UBARUBAR59DUBAR59D2019-08-02
D814UBAR620ProTech UBARUBAR62UBAR622019-08-02
D814UBAR62A0ProTech UBARUBAR62AUBAR62A2019-08-02
D814UBAR62B0ProTech UBARUBAR62BUBAR62B2019-08-02

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