FDA.report

PRO-SYS

Primary DI
00366975055040
Brand
PRO-SYS
Company
BENCO DENTAL SUPPLY CO.
Model
5400-924
Published
2022-08-04
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

Related Records

Product Codes

CodeName
JESFloss, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00366975055040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975055040003669750550403669750550400366975055040

GMDN Terms

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

Regulatory Flags

DUNS number
015108087
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
00366975069993Sterling6694-6422025-02-26
00366975070005Sterling5259-5162025-02-26
00366975069344STERLING5259-507 2024-01-26
00366975013040STERLING5259-5072023-12-13
00366975012814STERLING4983-5662023-06-13
00366975066848OPTIMUM6032-0532023-02-21
00366975066855OPTIMUM6032-0712023-02-21
00366975066862OPTIMUM6032-0802023-02-21
00366975066879OPTIMUM6032-0992023-02-21
00366975066886OPTIMUM6032-1062023-02-21
00366975066893OPTIMUM6032-1152023-02-21
00366975066909OPTIMUM6032-1242023-02-21
00366975066916OPTIMUM6032-1332023-02-21
00366975066923OPTIMUM6032-1422023-02-21
00366975066930OPTIMUM6032-1512023-02-21
00366975066947OPTIMUM6032-1602023-02-21
00366975066954OPTIMUM6032-1792023-02-21
00366975066961OPTIMUM6032-1972023-02-21
00366975066978OPTIMUM6032-2042023-02-21
00366975066992OPTIMUM6032-2312023-02-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06975843620002HIT PROMOTIONAL PRODUCTS, INC.YUYAO NEW POWER PROMOTION INDUSTRIAL CO., LTDJES2026-05-26
16931718175647HIT PROMOTIONAL PRODUCTS, INCNew Phenix Home Products Manufactory Co., Ltd.JES2026-03-03
008171690226333D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJES2025-12-16
16931718175616HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-08-05
D83230000EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323000B0EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323000T0EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D83231000FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323100B0FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323100T0FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
16931718175609HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-05-07
10810051081784GURUNANDA DUAL-SLICKER FLOSS PICKGurunanda, LLCJES2025-05-06
10810051083412GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGurunanda, LLCJES2025-05-06
00810051085532GURUNANDA EXPANDABLE FLOSSGurunanda, LLCJES2025-05-06
06973026120288MeizhikangMeizhikang Technology (Shenzhen) Co., Ltd.JES2025-04-21
16931718175586HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-04-18
00860009239623INNOVATION LINEInnovation SpecialtiesJES2025-04-15
00860009239630INNOVATION LINEInnovation SpecialtiesJES2025-04-15
20810063755564Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756189Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756196Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756653Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756660Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
00359883005696Re-Cord™ Knitted Retraction Cord #000DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005702Re-Cord™ Knitted Retraction Cord #00DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005719Re-Cord™ Knitted Retraction Cord #0DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005726Re-Cord™ Knitted Retraction Cord #1DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005733Re-Cord™ Knitted Retraction Cord #2DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005740Re-Cord™ Knitted Retraction Cord #3DEN-MAT HOLDINGS, LLCJES2025-03-12
00304040189818Henry ScheinHENRY SCHEIN, INC.JES2025-01-30