FDA.report

4oz POLARIS PURPLE GALAXY

Primary DI
D7750451070
Brand
4oz POLARIS PURPLE GALAXY
Company
GREAT LAKES ORTHODONTICS, LTD.
Model
045-107
Catalog number
045-107
Device description
4oz POLARIS PURPLE GALAXY
Published
2016-08-16
Public version status
Update
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7750451070PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Sterilization Methods

Method

Contacts

PhoneEmail
8008287626info@greatlakesortho.com

Regulatory Flags

DUNS number
041854332
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D7753004000SM DRYFIELD KIT RED *I 300-400 300-400 2016-05-18
D7753004010LG DRYFIELD KIT WHITE *I 300-401 300-401 2016-05-18
D7753004060RETRACTOR - LARGE WHITE *I 300-406 300-406 2016-05-18
D7753004140RETRACTOR - SMALL RED *I 300-414 300-414 2016-05-18
D7753006120LARGE LIP RETRACTOR *O 300-612 300-612 2016-05-18
D7753006140SMALL LIP RETRACTOR *O 300-614 300-614 2016-05-18
D7753006260GL INTRAORAL MOUTH PROPS 300-626 300-626 2016-05-18
D7753006270GL INTRAORAL MOUTH PROPS 300-627 300-627 2016-05-18
D7753006280GL INTRAORAL MOUTH PROPS 300-628 300-628 2016-05-18
D7753006290GL DOUBLE-ENDED CHEEK 300-629 300-629 2016-05-18
D7753006300GL DOUBLE-ENDED CHEEK 300-630 300-630 2016-05-18
D7753006310GL EXTRAORAL CHEEK RETRACTORS 300-631 300-631 2016-05-18
D7753006320GL EXTRAORAL CHEEK RETRACTORS 300-632 300-632 2016-05-18
D7751400151GL ACCULIGHT EXPANSION KEY 140-015 140-015 2016-05-18
D7751400201GLO EZKEY PKG/10 *O 140-020 140-020 2016-05-18
D7751910211GLO MOUTHGUARD - PINK (DZ) *I 191-021 191-021 2016-05-18
D7751910221GLO MOUTHGUARD PINK (DZ) *I 191-022 191-022 2016-05-18
D7751910231GLO MOUTHGUARD PURPLE (DZ) *I 191-023 191-023 2016-05-18
D7751910241GLO MOUTHGUARD PURPLE (DZ) *I 191-024 191-024 2016-05-18
D7751910251GLO MOUTHGUARD ASST'D (DZ) *I 191-025 191-025 2016-05-18

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