FDA.reportPublic FDA data

Sure-endo

Primary DI
08809264299562
Brand
Sure-endo
Company
SURE DENT CORPORATION
Model
SC-1
Device description
Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #1, 100 in (254cm)
Published
2023-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809264299562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809264299562088092642995628809264299562

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction cord, non-medicatedA non-medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688273010
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800069213302GuttaSeal ZX® Gutta Percha PointsG906 LB15.0324G906LB15032026-02-09
08800069213319GuttaSeal ZX® Gutta Percha PointsG906 LB15-40/.0324G906LB1540032026-02-09
08800069213326GuttaSeal ZX® Gutta Percha PointsG906 LB20.0324G906LB20032026-02-09
08800069213333GuttaSeal ZX® Gutta Percha PointsG906 LB25.0324G906LB25032026-02-09
08800069213340GuttaSeal ZX® Gutta Percha PointsG906 LB30.0324G906LB30032026-02-09
08800069213357GuttaSeal ZX® Gutta Percha PointsG906 LB35.0324G906LB35032026-02-09
08800069213364GuttaSeal ZX® Gutta Percha PointsG906 LB40.0324G906LB40032026-02-09
08800069213371GuttaSeal ZX® Gutta Percha PointsG906 LB45.0324G906LB45032026-02-09
08800069213388GuttaSeal ZX® Gutta Percha PointsG906 LB15.0524G906LB15052026-02-09
08800069213395GuttaSeal ZX® Gutta Percha PointsG906 LB15-40/.0524G906LB1540052026-02-09
08800069213401GuttaSeal ZX® Gutta Percha PointsG906 LB20.0524G906LB20052026-02-09
08800069213418GuttaSeal ZX® Gutta Percha PointsG906 LB25.0524G906LB25052026-02-09
08800069213425GuttaSeal ZX® Gutta Percha PointsG906 LB30.0524G906LB30052026-02-09
08800069213432GuttaSeal ZX® Gutta Percha PointsG906 LB35.0524G906LB35052026-02-09
08800069213449GuttaSeal ZX® Gutta Percha PointsG906 LB40.0524G906LB40052026-02-09
08800069213456GuttaSeal ZX® Gutta Percha PointsG906 LB45.0524G906LB45052026-02-09
08800069213463Absorbent Paper PointsP910 L15.0324P910L15032026-02-09
08800069213470Absorbent Paper PointsP910 L15-40/.0324P910L1540032026-02-09
08800069213487Absorbent Paper PointsP910 L20.0324P910L20032026-02-09
08800069213494Absorbent Paper PointsP910 L25.0324P910L25032026-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
D248938521Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
D2486054610Spandex Advanced Junior (Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
D2486054620Spandex Advanced Large ( Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603672Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603689Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-UseArmor Dental Corp.EIF2025-05-12
08800099963765Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963772Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963789Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963796Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963802Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963819Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963826Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963833Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963840Perfit ZRVatech mcis Co., LtdEIF2025-04-07