FDA.report

Nylon Bite Tray

Primary DI
00616784223025
Brand
Nylon Bite Tray
Company
DYNAREX CORPORATION
Model
2230
Device description
Nylon Bite Tray, Full Arch aka Quadrant, White
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00616784223025PackageGS130In Commercial Distribution
00616784223032PackageGS110In Commercial Distribution
00616784223018PrimaryGS10
00616784223001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784223025006167842230256167842230250616784223025
00616784223032006167842230326167842230320616784223032
00616784223018006167842230186167842230180616784223018
00616784223001006167842230016167842230010616784223001

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

Regulatory Flags

DUNS number
008124539
Device count
30
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810180843331Durma+ DynaRule Disposable Paper Rulers30062026-03-24
00810180845106Cotton Tipped Wood Applicators, Sterile43042022-04-22
00810180845113Cotton Tipped Wood Applicators, Sterile43052022-04-22
00810180840712CurPro Dermal Curettes,2 mm 41552024-12-16
00840117347892Medi-Cut Safety Scalpel41652022-04-17
00810180844901Disposable Prep Razors42512020-11-02
00810180844918Medicine Cups 1oz 42522024-10-28
00810180844925LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal 42542021-06-21
00810180844703Bandage Shears 7.5" Orange4183-BX2020-11-08
00810180844710Bandage Shears 7.5" Purple4184-BX2020-11-08
00810180844840Emesis Basin42242022-05-02
00810180844857Sitz Bath42282021-09-01
00810180844864Urinal- Male42292021-09-01
00810180844871Bed Pans42302021-04-22
00810180844888Bed Pans42312021-04-22
00810180844895Nuns Cap Specimen Collector42322021-04-22
00840117331822DynaSafety Heavy Duty Woven Fabric Knuckle Bandages, 1 1/2" x 3"3765BULK2024-03-08
00840117331853DynaSafety Heavy Duty Woven Fabric Bandages, Large Patch, 2" x 3"3766BULK2024-03-08
00840117331907DynaSafety Heavy Duty Woven Fabric Bandages, Sterile, 7/8" x 3"3767BULK2024-03-08
00840117350045Pill Crusher Pouch42102021-09-01

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