FDA.report

Astek

Primary DI
00840326419366
Brand
Astek
Company
Young Innovations, Inc.
Model
118209
Catalog number
118209
Device description
#9 Transform Edentulous Tray Medium Lower
Published
2024-10-25
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
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications

CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840326419366PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags

DUNS number
004193103
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
E241VT0220Cavex Bleach Transparent 1,0 mmCavex Holland B.V.EHY2026-03-10
28906139322081Taglus Impression TrayLAXMI DENTAL LIMITEDEHY2026-01-09
00723896030295ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030387ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030417ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030448ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030479ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/PackPRACTICON, INC.EHY2026-01-08
00723896030509ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/PackPRACTICON, INC.EHY2026-01-08
00723896030530ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030561ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030592ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/PackPRACTICON, INC.EHY2026-01-08
00817169023890Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEHY2025-12-16
06977979289856AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
06978447935008AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
06978447938504AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
10190707193192Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
10190707193208Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
10190707110786DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110793DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110809DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110816DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110823DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110830DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110847DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110854DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110861DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110878DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110885DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25