FDA.reportPublic FDA data

COMPLETE DENTAL SUPPLIES

Primary DI
00850055627581
Brand
COMPLETE DENTAL SUPPLIES
Company
Complete Dental Supplies LLC
Model
20374-CDS
Device description
Micro Applicators, Plastic Canister Packaging #3, Regular Size 100pcs/tube
Published
2023-09-25
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
KXRApplicator, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055627581PrimaryGS10
00850055627598Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055627581008500556275818500556275810850055627581
00850055627598008500556275988500556275980850055627598

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Regulatory Flags#

DUNS number
054494926
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055627000COMPLETE DENTAL SUPPLIES20460-CDS2023-09-06
00850055627154COMPLETE DENTAL SUPPLIES20468-CDS2023-09-06
00850055627406COMPLETE DENTAL SUPPLIES20458-CDS2023-09-22
00850055627598COMPLETE DENTAL SUPPLIES20374-CDS2023-09-25
00850055627147COMPLETE DENTAL SUPPLIES20470-CDS2023-09-22
00850055627178COMPLETE DENTAL SUPPLIES20465-CDS2023-09-22
00850055627383COMPLETE DENTAL SUPPLIES20547-CDS2023-09-22
00850055627420COMPLETE DENTAL SUPPLIES20367-CDS2023-09-22
00850055627444COMPLETE DENTAL SUPPLIES20368-CDS2023-09-22
00850055627468COMPLETE DENTAL SUPPLIES20472-CDS2023-09-22
00850055627482COMPLETE DENTAL SUPPLIES20473-CDS2023-09-22
00850055627505COMPLETE DENTAL SUPPLIES20474-CDS2023-09-22
00850055627529COMPLETE DENTAL SUPPLIES20475-CDS2023-09-22
00850055627543COMPLETE DENTAL SUPPLIES20476-CDS2023-09-22
00850055627567COMPLETE DENTAL SUPPLIES20477-CDS2023-09-22
00850055627369COMPLETE DENTAL SUPPLIES20470-CDS2023-09-22
00850055627376COMPLETE DENTAL SUPPLIES20465-CDS2023-09-22
00850055627390COMPLETE DENTAL SUPPLIES20547-CDS2023-09-22
00850055627413COMPLETE DENTAL SUPPLIES20458-CDS2023-09-22
00850055627437COMPLETE DENTAL SUPPLIES20367-CDS2023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456202401JMUJMU DENTAL, INCKXR2026-07-08
00840456223222JMUJMU DENTAL, INCKXR2026-07-08
00840456223239JMUJMU DENTAL, INCKXR2026-07-08
D1257500B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502T4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502W4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125902D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125902TLG1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903T2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903TLL1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904T2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21