FDA.reportPublic FDA data

TPH Spectra ST

Primary DI
D0106425421
Brand
TPH Spectra ST
Company
Dentsply De Trey GmbH
Model
642542
Catalog number
642542
Device description
TPH Spectra ST Effects Compules Tips Intro Kit is a visible light-cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and permanent teeth.
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, tooth shade, resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0106425421PrimaryHIBCC0
D0106425420Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze.
Special Storage Condition, Specify00Keep out of direct sunlight and protect from moisture.
Storage Environment Temperature2 Degrees Celsius28 Degrees Celsius

Regulatory Flags#

DUNS number
315471722
Device count
28
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D01060620110N1AH Plus Endodontic Sealer60620110N60620110N2026-08-26
D01060620110NA1AH Plus Endodontic Sealer60620110NA60620110NA2025-03-31
D01060620118NA1AH Plus Jet Endodontic Sealer Syringe Refill60620118NA60620118NA2025-03-31
D010644500401SmartLite Focus64450040644500402020-12-16
D01060620115NA1AH Plus Jet Endodontic Sealer Starter Kit60620115NA60620115NA2025-03-31
D010644500201SMARTLITE FOCUS64450020644500202017-03-16
D010644500211SmartLite Focus64450021644500212020-12-16
D010644500501SmartLite Focus64450050644500502020-12-16
D010644500701SmartLite Focus64450070644500702020-12-16
D0106420161TPH Spectra ST6420166420162025-12-11
D0106420160TPH Spectra ST6420166420162025-12-11
D01060620118NA0AH Plus Jet Endodontic Sealer Syringe Refill60620118NA60620118NA2025-03-31
D010606659001Compules Tips Gun60665900606659002023-08-10
D0106425401TPH Spectra ST6425406425402024-02-27
D0106425411TPH Spectra ST6425416425412024-02-27
D0106425431TPH Spectra ST6425436425432024-02-27
D0106425441TPH Spectra ST6425446425442024-02-27
D0106425451TPH Spectra ST6425456425452024-02-27
D0106425400TPH Spectra ST6425406425402024-02-27
D0106425410TPH Spectra ST6425416425412024-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208477825Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
07615208477832Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
00810111543644QuantiumBISCO INC.EBF2026-10-12
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBF2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00197998226724Solventum™ Protemp™Solventum Germany GmbHEBF2026-10-08
08806383540995DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541008DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541015DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541022DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541039DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541046DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541060DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541107DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541114DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541121DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541138DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541145DIAFILDiaDent Group InternationalEBF2026-10-07