FDA.report

Dental City

Primary DI
D7715310020
Brand
Dental City
Company
ICP, INC.
Model
53-1002
Published
2021-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KXRApplicator, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D771531002PrimaryHIBCC0
D7715310020Unit of UseHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
808371371
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D77114705LG0Stratus14-705LG2026-03-24
D77114705MD0Stratus14-705MD2026-03-24
D77114705SM0Stratus14-705SM2026-03-24
D77114705XL0Stratus14-705XL2026-03-24
D77114705XS0Stratus14-705XS2026-03-24
D7714227200BG0Dental City42-27200BG42-27200BG2026-03-24
D7714227200M0Dental City42-27200M42-27200M2026-03-24
D7714227200ML0Dental City42-27200ML2026-03-24
D771422750ML0Dental City42-2750ML2026-03-24
D77116100LG0Guardian16-100LG2026-03-19
D77116100MD0Guardian16-100MD2026-03-19
D77116100SM0Guardian16-100SM2026-03-19
D77116100XL0Guardian16-100XL2026-03-19
D77116100XS0Guardian16-100XS2026-03-19
D77114701LG0Dental City14-701LG2023-06-02
D77114701MD0Dental City14-701MD2023-06-02
D77114701SM0Dental City14-701SM2023-06-02
D77114701XL0Dental City14-701XL2023-06-02
D77114701XS0Dental City14-701XS2023-06-02
D77114715LG0Dental City14-715LG2023-06-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07615208482416OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208482423OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590500OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590678OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590494OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208482768OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208488401OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445596OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445602OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208486254OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445947OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
EKUR000967KA0Disposable brush tips (black)KURARAY NORITAKE DENTAL INC.KXR2025-08-22
EKUR000968KA0Disposable brush tips (white)KURARAY NORITAKE DENTAL INC.KXR2025-08-22
00883205021809Inspiral Brush TipULTRADENT PRODUCTS, INC.KXR2025-08-19
10818207025033Traxodent Gel Brush TipsVista DentalKXR2025-06-30
08800019116608NeoGlide Resin InstrumentsB& L Biotech, inc.KXR2025-06-18
08800019116615NeoGlide Resin InstrumentsB& L Biotech, inc.KXR2025-06-18
00789594000046MicrobrushYOUNG MICROBRUSH, LLCKXR2025-06-13
10789594000050MicrobrushYOUNG MICROBRUSH, LLCKXR2025-06-13
00359883002718Multi-Brush® (Yellow)DEN-MAT HOLDINGS, LLCKXR2025-03-12
00359883003449Multi-Brush® (Blue)DEN-MAT HOLDINGS, LLCKXR2025-03-12
00359883004019Temptation® 10L Syringe Mixing TipsDEN-MAT HOLDINGS, LLCKXR2025-03-12
D701T20G191Applicator TipsPULPDENT CORPORATIONKXR2024-12-03
EKUR001024KA1Applicator brush (fine<silver>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
EKUR001025KA0Applicator brush (endo<black>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
EKUR001221KA0Applicator brush (superfine<white>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
00000008857972RMORmo, Inc.KXR2024-08-12
D956DVNRSTI0DSI Veneer Stick Adhesive Tip Holders 16pcsD.S.I DENTAL SOLUTIONS LTDKXR2024-06-27
D974BSI20032BritedentBright Supply, Inc.KXR2024-06-07
20889989061455OrmcoORMCO CORPORATIONKXR2024-03-07