FDA.reportPublic FDA data

Pac-Dent

Primary DI
00815967021544
Brand
Pac-Dent
Company
PAC-DENT INTERNATIONAL INC
Model
8022
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00815967021544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815967021544008159670215448159670215440815967021544

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
959077454
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815967020001Pac-Dent1002016-08-26
10815967020032Pac-Dent100B2016-08-26
10815967020049Pac-Dent1012016-08-29
10815967020056Pac-Dent1042016-08-29
10815967020063Pac-Dent101A2016-08-29
10815967020070Pac-Dent1022016-08-29
10815967020087Pac-Dent1032016-08-26
10815967020094Pac-Dent1122016-08-29
10815967020100Pac-Dent1112016-08-26
10815967020117Pac-Dent111SG2016-08-29
10815967020124Pac-Dent1102016-08-26
10815967020131Pac-Dent1092016-08-29
10815967020148Pac-Dent103HP2016-08-29
10815967020155Pac-Dent104HP2016-08-29
10815967020162Pac-DentP45502016-08-29
10815967020728Pac-DentPPE-248-22016-08-26
10815967022081Pac-DentPE-VI-122016-09-23
10815967022173Pac-DentC1012016-12-27
10815967022180Pac-DentC101B2016-12-27
00815967020424Pac-Dent190LED2016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
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