FDA.report

Supplies

Primary DI
00190746030901
Brand
Supplies
Company
AMERICAN ORTHODONTICS CORPORATION
Model
861-016
Catalog number
861-016
Device description
SUPPLIES - LAMINATED BITE WAFER 84/PKG
Published
2022-04-05
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EGDWAX, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190746030901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746030901001907460309011907460309010190746030901

GMDN Terms

TermDefinition
Bite registration rim wax, plateA dental material (modelling wax) delivered as prefabricated plates of wax with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags

DUNS number
044668515
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

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