FDA.reportPublic FDA data

Gingi-Plain Max Z-Twist

Primary DI
00818746020097
Brand
Gingi-Plain Max Z-Twist
Company
Gingi Pak
Model
11170M
Device description
Non-medicated, Braided Gingival Retraction Cord, 108 inches, Size: 00
Published
2026-08-26
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
00818746020097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818746020097008187460200978187460200970818746020097

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction cord, non-medicatedA non-medicated cotton string intended to be used to temporarily push gum tissue (gingiva) away from prepared tooth margins to help make an accurate dental impression. This is a single-use device.

Regulatory Flags#

DUNS number
008480121
Device count
1
DM exempt
false
Premarket exempt
false
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
00818746020042Gingi-Plain Max Soft-Twist11105M2026-08-26
00818746020073Gingi-Plain Max Z-Twist11172M2026-08-26
00818746020080Gingi-Plain Max Z-Twist11171M2026-08-26
00818746020103Gingi-Plain Max Z-Twist1117TM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818746020042Gingi-Plain Max Soft-TwistGingi PakJES2026-08-26
00818746020073Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020080Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020103Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00840456224762JMUJMU DENTAL, INCJES2026-08-18
00070942008334GUM®SUNSTAR AMERICAS, INC.JES2026-07-28
00840456214701JMUJMU DENTAL, INCJES2026-07-24
00840456214718JMUJMU DENTAL, INCJES2026-07-24
06931718175657HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
06931718175664HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
06931718175671HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
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