FDA.report

Atmos

Primary DI
00190746150968
Brand
Atmos
Company
AMERICAN ORTHODONTICS CORPORATION
Model
909-030665
Catalog number
909-030665
Device description
SUPPLIES ATMOS THERMOFORMING MATERIAL .035 120mm CIRCLE 100/PK
Published
2020-02-10
Public version status
New
Distribution status
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
KMYPOSITIONER, TOOTH, PREFORMED

Product Code Classifications

CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190746150968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746150968001907461509681907461509680190746150968

GMDN Terms

TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Light
Special Storage Condition, Specify00Keep Away from Light, Keep Dry
Storage Environment Temperature6 Degrees Celsius27 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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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