FDA.reportPublic FDA data

SDFlosser Trial Pack

Primary DI
00723896019535
Brand
SDFlosser Trial Pack
Company
PRACTICON, INC.
Model
7042640
Catalog number
7042640
Device description
SILVER DIAMINE FLUORIDE FLOSSER, TO DISPENSE AND PLACE ACCURATELY SDF
Published
2021-07-23
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

Product Codes#

Code, Name table
CodeName
JESFloss, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00723896019535PackageGS110In Commercial Distribution
00723896019528PrimaryGS10
00723896019511Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896019535007238960195357238960195350723896019535
00723896019528007238960195287238960195280723896019528
00723896019511007238960195117238960195110723896019511

GMDN Terms#

Term, Definition table
TermDefinition
Dental flossA string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119193803
Device count
10
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00723896029848Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029879Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029909Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030288ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030318ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030349ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08
00723896030370ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack715825271582522026-01-08
00723896030400ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack715825371582532026-01-08
00723896030431ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/Pack715825471582542026-01-08
00723896030462ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/Pack715825571582552026-01-08
00723896030493ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/Pack715825671582562026-01-08
00723896030523ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/Pack715825771582572026-01-08
00723896030554ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/Pack715825871582582026-01-08
00723896030585ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/Pack715825971582592026-01-08
00723896029855Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029886Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030295ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00070942008822GUM® Expanding FlossSUNSTAR AMERICAS, INC.JES2026-05-01
00070942008952GUM® Professional Clean FlossSUNSTAR AMERICAS, INC.JES2026-04-30
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERSSUNSTAR AMERICAS, INC.JES2025-11-04
10371347019732Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
10371347019749Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-06-25
10810063755567Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756182Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756199Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756656Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756663Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10304040189853Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189860Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189877Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189884Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
00032251933462Family WellnessFamily Dollar StoresJES2024-05-03
00032251933486Family WellnessFamily Dollar StoresJES2024-05-03
00032251933493Family WellnessFamily Dollar StoresJES2024-05-03
00032251933523Family WellnessFamily Dollar StoresJES2024-05-03
00032251933479Family WellnessFamily Dollar StoresJES2024-04-09
00032251933509Family WellnessFamily Dollar StoresJES2024-04-09
00070942007153GUM®SUNSTAR AMERICAS, INC.JES2024-04-05
00070942007177GUM®SUNSTAR AMERICAS, INC.JES2024-04-05
00070942006590GUM®SUNSTAR AMERICAS, INC.JES2024-03-15
00070942006552GUM®SUNSTAR AMERICAS, INC.JES2024-03-14
00070942006576GUM®SUNSTAR AMERICAS, INC.JES2024-03-13
00070942006514GUM®SUNSTAR AMERICAS, INC.JES2024-03-12
00070942006613GUM®SUNSTAR AMERICAS, INC.JES2024-03-12
00070942006606GUM®SUNSTAR AMERICAS, INC.JES2024-03-07
00070942006583GUM®SUNSTAR AMERICAS, INC.JES2024-03-05