FDA.reportPublic FDA data

TUFF-TEMP PLUS

Primary DI
D701TTP5A12
Brand
TUFF-TEMP PLUS
Company
PULPDENT CORPORATION
Model
TTP5A1
Device description
TUFF-TEMP PLUS 5ML A1 SHADE 5 ml syringe + 8 automix tips
Published
2019-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D701TTP5A12PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridge resinA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001006089
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D701DEN2DENTIN CONDITIONING GELDEN2016-07-21
D701EA2ETCH-ALL™ EA2016-09-01
D701EA52ETCH-ALL™ Dental Etching Gel EA52016-07-28
D701ER2ETCH ROYALE™ DENTAL ETCHING GELER2016-08-11
D701ER242ETCH ROYALE™ DENTAL ETCHING GEL ER242016-08-11
D701ER502ETCH ROYALE™ DENTAL ETCHING GELER502016-08-11
D701ER50R2Etch RoyaleER50R2016-09-01
D701ER62ETCH ROYALE™ DENTAL ETCHING GEL ER62016-08-11
D701ET122ETCH-RITE™ DENTAL ETCHING GEL ET122016-07-28
D701ET12G2ETCH-RITE™ DENTAL ETCHING GEL ET12G2016-07-28
D701ET182ETCHANTET182016-09-01
D701ET242ETCH-RITE™ DENTAL ETCHING GEL ET242016-08-11
D701ET502ETCH-RITE™ DENTAL ETCHING GEL ET502016-08-11
D701ET50R2ETCH-RITE™ DENTAL ETCHING GELET50R2016-08-11
D701ET62ETCH-RITE™ DENTAL ETCHING GELET62016-07-28
D701ETCH2ETCH-RITE™ DENTAL ETCHING GELETCH2016-07-28
D701ETTWIN2ETCH-RITE™ DENTAL ETCHING GEL ETTWIN2016-07-28
D701SER2ETCH ROYALE SAMPLESER2018-08-10
D701SETCH2ETCH RITE SAMPLESETCH2018-08-10
D701ET1442ETCH-RITE™ DENTAL ETCHING GEL ET1442016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998226748Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226755Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226762Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226823Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
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