FDA.report

Anterior Impression Tray

Primary DI
00616784223834
Brand
Anterior Impression Tray
Company
DYNAREX CORPORATION
Model
2238
Device description
Anterior Impression Tray/Upper #9 Bag Size 25x17, 12pcs
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
EHZEvacuator, Oral Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784223834PackageGS110In Commercial Distribution
00616784223810PrimaryGS10
00616784223803Unit of UseGS10
00810180843591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784223834006167842238346167842238340616784223834
00616784223810006167842238106167842238100616784223810
00616784223803006167842238036167842238030616784223803
00810180843591008101808435918101808435910810180843591

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
12
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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