FDA.report

Nylon Bite Tray

Primary DI
00616784222820
Brand
Nylon Bite Tray
Company
DYNAREX CORPORATION
Model
2228
Device description
Nylon Bite Tray 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
00616784222820PackageGS135In Commercial Distribution
00616784222837PackageGS110In Commercial Distribution
00616784222813PrimaryGS10
00616784222806Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784222820006167842228206167842228200616784222820
00616784222837006167842228376167842228370616784222837
00616784222813006167842228136167842228130616784222813
00616784222806006167842228066167842228060616784222806

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
35
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

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