FDA.reportPublic FDA data

iSmile

Primary DI
20816419021499
Brand
iSmile
Company
Ismile Dental Products, Inc.
Model
20-2001
Catalog number
20-2001
Device description
Utility Syringe Curved 12cc
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816419021495PrimaryGS10
20816419021499Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816419021495008164190214958164190214950816419021495
2081641902149920816419021499

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, reusableA non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
016765988
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 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
10841767195717Trinity Sterile, Inc.Trinity Sterile, Inc.KYZ2026-08-25
10080196456765MEDLINEMEDLINE INDUSTRIES, INC.KYZ2026-07-14
10080196031764MEDLINEMEDLINE INDUSTRIES, INC.KYZ2026-07-13
10198956501645CARDINAL HEALTHCardinal Health 200, LLCKYZ2026-06-08
10198956466579CARDINAL HEALTHCardinal Health 200, LLCKYZ2026-05-19
10653160392859Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KYZ2026-04-08
10192253068856MonojectCardinal Health 200, LLCKYZ2026-01-29
10192253068863MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068884MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068891MonojectCardinal Health 200, LLCKYZ2026-01-29
10192253007442MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007480MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007510MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007534MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007558MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007732MonojectCardinal Health 200, LLCKYZ2025-12-15
00661392004474LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392007437LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392010734LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392010758LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392055124LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392055155LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
10198956204768CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-10
10198956194649CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
10198956181540CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
10704411006152AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007074AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007098AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
00661392002258LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002265LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16