GuttaSeal ZX® Gutta Percha Points 24G906LB4003

GUDID 88800069213360

GuttaSeal ZX® Gutta Percha Points, 40.03, Slide, 60p, Length marked

SURE DENT CORPORATION

Synthetic gutta-percha
Primary Device ID88800069213360
NIH Device Record Keyc364f4a0-8f9c-4d87-927e-2f3aa17fd40d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuttaSeal ZX® Gutta Percha Points
Version Model NumberG906 LB40.03
Catalog Number24G906LB4003
Company DUNS688273010
Company NameSURE DENT CORPORATION
Device Count60
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool area and avoid exposure to sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS108800069213364 [Primary]
GS188800069213360 [Unit of Use]

FDA Product Code

EKMGutta-Percha

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-17
Device Publish Date2026-02-09

On-Brand Devices [GuttaSeal ZX® Gutta Percha Points]

88800069213452GuttaSeal ZX® Gutta Percha Points, 45.05, Slide, 60p, Length marked
88800069213445GuttaSeal ZX® Gutta Percha Points, 40.05, Slide, 60p, Length marked
88800069213438GuttaSeal ZX® Gutta Percha Points, 35.05, Slide, 60p, Length marked
88800069213421GuttaSeal ZX® Gutta Percha Points, 30.05, Slide, 60p, Length marked
88800069213414GuttaSeal ZX® Gutta Percha Points, 25.05, Slide, 60p, Length marked
88800069213407GuttaSeal ZX® Gutta Percha Points, 20.05, Slide, 60p, Length marked
88800069213391GuttaSeal ZX® Gutta Percha Points, 15-40.05, Slide, 60p, Length marked
88800069213384GuttaSeal ZX® Gutta Percha Points, 15.05, Slide, 60p, Length marked
88800069213377GuttaSeal ZX® Gutta Percha Points, 45.03, Slide, 60p, Length marked
88800069213360GuttaSeal ZX® Gutta Percha Points, 40.03, Slide, 60p, Length marked
88800069213353GuttaSeal ZX® Gutta Percha Points, 35.03, Slide, 60p, Length marked
88800069213346GuttaSeal ZX® Gutta Percha Points, 30.03, Slide, 60p, Length marked
88800069213339GuttaSeal ZX® Gutta Percha Points, 25.03, Slide, 60p, Length marked
88800069213322GuttaSeal ZX® Gutta Percha Points, 20.03, Slide, 60p, Length marked
88800069213315GuttaSeal ZX® Gutta Percha Points, 15-40.03, Slide, 60p, Length marked
88800069213308GuttaSeal ZX® Gutta Percha Points, 15.03, Slide, 60p, Length marked

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