FDA.reportPublic FDA data

iSmile

Primary DI
00816419021457
Brand
iSmile
Company
Ismile Dental Products, Inc.
Model
20-0595
Catalog number
20-0595
Device description
VP Micro Brush Applicator Regular Orange
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJBHandle, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816419021457PrimaryGS10
20816419021451Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816419021457008164190214578164190214570816419021457
2081641902145120816419021451

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.

Contacts#

Phone, Email table
PhoneEmail
916-928-0359info@ismiledp.com

Regulatory Flags#

DUNS number
016765988
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816419020078iSmile25-200325-20032023-06-21
00816419020085iSmile25-200425-20042023-06-21
00816419020771iSmile45-153645-15362024-09-27
20816419020775iSmile45-153645-15362024-09-27
00816419021532iSmile25-300125-30012023-06-21
00816419021549iSmile25-300325-30032023-06-21
00816419021556iSmile25-300525-30052023-06-21
00816419021563iSmile25-300725-30072023-06-21
00816419021570iSmile25-300225-30022023-06-21
00816419021587iSmile25-300425-30042023-06-21
00816419021594iSmile25-300625-30062023-06-21
00816419021600iSmile25-300825-30082023-06-21
00816419021617iSmile25-301025-30102023-06-21
00816419021624iSmile25-301125-30112023-06-21
00816419021853iSmile65-600565-60052023-06-21
00816419021860iSmile65-601065-60102023-06-21
00816419021877iSmile65-601565-60152023-06-21
00816419021945iSmile45-000145-00012023-06-21
00816419021952iSmile45-000245-00022023-06-21
00816419021969iSmile45-000945-00092023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622142Strip PlacerMELPEX BEAUTY INSTRUMENTSEJB2026-05-21
G149TBSB3100TBS BASICSACME ENTERPRISE.EJB2026-05-16
08809260472853TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472860TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472877TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472884TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472891TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472907TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472914TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472921TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
G149NP360100NPSACME ENTERPRISE.EJB2026-05-01
G149NP380630NPSACME ENTERPRISE.EJB2026-05-01
EZPF26179500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179510HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179550HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179560HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179570HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179580HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179590HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
10371347017721Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
10371347017745Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
08800075626905OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627230OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627247OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627254OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627674OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627681OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627735OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627742OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627759OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03