FDA.reportPublic FDA data

TPH Spectra ST

Primary DI
D0106425451
Brand
TPH Spectra ST
Company
Dentsply De Trey GmbH
Model
642545
Catalog number
642545
Device description
TPH Spectra ST Effects Compules Tips Refill E1 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
D0106425451PrimaryHIBCC0
D0106425450Unit 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
16
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D01060620118NA1AH Plus Jet Endodontic Sealer Syringe Refill60620118NA60620118NA2025-03-31
D010644500401SmartLite Focus64450040644500402020-12-16
D01060620110NA1AH Plus Endodontic Sealer Tubes60620110NA60620110NA2025-03-31
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
D0106425421TPH Spectra ST6425426425422024-02-27
D0106425431TPH Spectra ST6425436425432024-02-27
D0106425441TPH Spectra ST6425446425442024-02-27
D0106425400TPH Spectra ST6425406425402024-02-27
D0106425410TPH Spectra ST6425416425412024-02-27
D0106425420TPH Spectra ST6425426425422024-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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