FDA.reportPublic FDA data

Dentray II

Primary DI
D687AD33060FG1
Brand
Dentray II
Company
Sultan Healthcare Inc
Model
AD33057FG
Catalog number
AD33060FG
Device description
Dentray II #10P Lower Anterior Perforated Package of 12
Published
2022-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D687AD33060FG1PrimaryHIBCC0
D687AD33060FG0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Regulatory Flags#

DUNS number
056296981
Device count
12
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D6870031103FG1Durashield® CV0031103FG2016-09-23
D6870031104FG1Durashield® CV0031104FG2016-09-23
D6870031105FG1Durashield® CV0031105FG2016-09-23
D6870031106FG1Durashield® CV0031106FG2016-09-23
D6870020361SA1Com-Fit0020361SA2017-07-18
D687215001Cleanlets21500215002022-11-30
D687215051Cleanlets21505215052022-11-30
D687215201ReSURGE™ 21520215202022-12-05
D687AD320121Topex® AD32012AD320122022-12-05
D687AD33004FG13-WayAD33000FGAD33004FG2022-12-05
D687215200ReSURGE™ 21520215202022-12-05
D687215211ReSURGE™ 21521215212022-12-05
D687AD320120Topex® AD32012AD320122022-12-05
D687AD33004FG03-WayAD33000FGAD33004FG2022-12-05
D687AD320101Topex® AD32010AD320102022-12-03
D687AD320111Topex® AD32010AD320112022-12-03
D687AD320131Topex® AD32010AD320132022-12-03
D687AD321011Topex® AD32010AD321012022-12-03
D687AD321021Topex® AD32010AD321022022-12-03
D687AD321031Topex® AD32010AD321032022-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D1254114Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254124Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254134Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254144Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254154Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254164Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254184Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254194Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254204Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254304Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
08961104622654Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08961104622661Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08906139322087Taglus Impression TrayLAXMI DENTAL LIMITEDEHY2026-01-09
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07615208301304Centric TrayIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHY2025-03-20