Prime Dent Etchant Liquid

Primary DI
00817441023136
Brand
Prime Dent Etchant Liquid
Company
PRIME DENTAL
Model
008-040
Device description
Etchant gel and conditioner.
Published
2023-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
K001108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001108000PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIALPrime Dental Manufacturing, Inc.2000-05-30EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817441023136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817441023136008174410231368174410231360817441023136

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

Contacts#

Phone, Email table
PhoneEmail
773-283-2914qa@primedentalmfg.com

Regulatory Flags#

DUNS number
027480775
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817441020005Prime-Dent Visible Light Cure Nano-Hybrid Composite001-6102016-08-10
00817441022658Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive006-0302023-11-21
00817441022269Prime-CrownA12019-11-06
00817441023433Prime Dent Tray Adhesive Blue017-0202017-01-04
00817441023549Scott's Select RC Cream 2-9gm Syringe199-10362016-09-26
00817441020012Prime Dent Visible Light Cure Nano Hybrid Composite Shade001-601A12019-11-06
00817441020029Prime Dent Visible Light Cure Nano Hybrid Composite 001-601A22019-11-06
00817441023556Prime-Core Chemical Cure Core Build Up003-0182017-01-04
00817441020326Prime Dent Visible Light Cure Hybrid Composite Shade A3001-001A32017-01-04
00817441020524Prime Dent Visible Light Cure Hybrid Composite Shade A2001-001A12017-01-04
00817441020548Prime Dent Flowable Composite Shade A3.5004-010A3.52017-01-04
00817441020722Prime Dent Flowable Composite Shade A1004-010A12017-01-04
00817441020739Prime Dent Flowable Composite Shade A2004-101A22017-01-04
00817441020999Prime Dent Visible Light Cure Micro Hybrid Composite001-4142017-01-04
00817441023532Scott's Select Temporary Cement NE Jars199-10092016-09-26
00817441023563Prime-Core DC Automix Core Build Up Material003-0612017-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08806383541152DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541169DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541176DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541183DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541190DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541206DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541213DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541220DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541237DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541244DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541251DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541268DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541299DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541305DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541312DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541329DIAFILDiaDent Group InternationalEBF2026-10-07