FDA.reportPublic FDA data

Acorn Single Dose Caps. Incisal

Primary DI
D83600331
Brand
Acorn Single Dose Caps. Incisal
Company
DENT ZAR, INC.
Model
0033
Catalog number
0033
Device description
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
Published
2016-09-02
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960565000ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVEDent Zar, Inc.1996-03-22EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D83600331PrimaryHIBCC0
D83600330Unit 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
789664455
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D83600400Dental Etchant (Enamel Conditioner), 12g Syringe004000402016-09-04
D83600540Dental Etchant (Enamel Conditioner), 1kg Bottle005400542016-09-04
D83600210Z Bond-Visible Light Cure One-Step Bonding Adhesive002100212016-09-03
D83600500Bonding Agent Visible Light Cure005000502016-09-03
D83610181Bonding Agent (Self-Cure) Part A & Part B101810182016-09-03
D836TKJGX4Polishers120242022-03-08
D836PSLFH9LED Curing Light120232022-03-07
D836QXGZK2Dental Diamond Burs120222022-03-07
D83600080Acorn Nano Micro Hybrid-Syringe Shade A1000800082016-09-02
D83600090Acorn Nano Micro Hybrid-Syringe Shade A2000900092016-09-02
D83600100Acorn Nano Micro Hybrid-Syringe Shade A3001000102016-09-02
D83600110Acorn Nano Micro Hybrid-Syringe Shade B2001100112016-09-02
D83600120Acorn Nano Micro Hybrid-Syringe Shade A4001200122016-09-02
D83600130Acorn Nano Micro Hybrid-Syringe Shade B3001300132016-09-02
D83600140Acorn Nano Micro Hybrid-Syringe Shade C2001400142016-09-02
D83600150Acorn Nano Micro Hybrid-Syringe Shade D3001500152016-09-02
D83600160Acorn Nano Micro Hybrid-Syringe Shade A3.5001600162016-09-02
D83600170Acorn Nano Micro Hybrid-Syringe Shade C3001700172016-09-02
D83600180Acorn Nano Micro Hybrid-Syringe Shade B1001800182016-09-02
D83600190Acorn Nano Micro Hybrid-Syringe Incisal001900192016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
06975338702916SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702923SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702930SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702947SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702992SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703005SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703012SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703029SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703074SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703388SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
00348783000917MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-01
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29