FDA.reportPublic FDA data

SPRUZZO POWDER

Primary DI
D772ATI4000390
Brand
SPRUZZO POWDER
Company
AMERICAN TOOTH INDUSTRIES
Model
040-400039
Device description
SPRUZZO BLUE 4 OZ POWDER
Published
2023-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D772ATI4000390PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental acrylic resinA non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
161532999
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D722ATI199925560CARBIDE BURRS016-19992-5562023-11-17
D772ATI1999220CARBIDE BURRS016-19992-22023-11-17
D772ATI1999230CARBIDE BURRS016-19992-32023-11-17
D772ATI199923350CARBIDE BURRS016-19992-33-52023-11-17
D772ATI19992340CARBIDE BURRS016-19992-342023-11-17
D772ATI19992350CARBIDE BURRS016-19992-352023-11-17
D772ATI19992360CARBIDE BURRS016-19992-362023-11-17
D772ATI19992370CARBIDE BURRS016-19992-372023-11-17
D772ATI19992380CARBIDE BURRS016-19992-382023-11-17
D772ATI19992390CARBIDE BURRS016-19992-392023-11-17
D772ATI1999240CARBIDE BURRS016-19992-42023-11-17
D772ATI1999250CARBIDE BURRS016-19992-52023-11-17
D772ATI199925570CARBIDE BURRS016-19992-5572023-11-17
D772ATI199925580CARBIDE BURRS016-19992-5582023-11-17
D772ATI199925590CARBIDE BURRS016-19992-5592023-11-17
D772ATI19992560CARBIDE BURRS016-19992-562023-11-17
D772ATI199925600CARBIDE BURRS016-19992-5602023-11-17
D772ATI19992570CARBIDE BURRS016-19992-572023-11-17
D772ATI19992580CARBIDE BURRS016-19992-582023-11-17
D772ATI19992590CARBIDE BURRS016-19992-592023-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10140Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10150Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10160Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10170Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10180Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10190Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10200Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10210Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17