FDA.report

Supplies

Primary DI
00190746034893
Brand
Supplies
Company
AMERICAN ORTHODONTICS CORPORATION
Model
861-200
Catalog number
861-200
Device description
SUPPLIES - ORTHODONTIC WAX 100/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
00190746034893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746034893001907460348931907460348930190746034893

GMDN Terms

TermDefinition
Orthodontic appliance relief materialA device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Light
Storage Environment Temperature055 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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