FDA.reportPublic FDA data

iSmile

Primary DI
00816419020122
Brand
iSmile
Company
Ismile Dental Products, Inc.
Model
25-4092
Catalog number
25-4092
Device description
"VP Patient Bib 2-Ply Paper + 1-Ply Poly 13"" x 18"" Green"
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
KHRAbsorber, Saliva, Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816419020122PrimaryGS10
10816419020129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816419020122008164190201228164190201220816419020122
1081641902012910816419020129

GMDN Terms#

Term, Definition table
TermDefinition
Patient examination/treatment drape, single-useA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
016765988
Device count
500
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
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10371347011439Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011446Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011453Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011460Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011477Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011484Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011491Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011507Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
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50732224004858Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004865Poly-Gard TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004872Poly-Gard TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224005060Professional Thrift TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224005077Professional Thrift TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
00816419020115iSmileIsmile Dental Products, Inc.KHR2023-06-21