FDA.report

GL - TAPERED WAFER (25)

Primary DI
D7752600321
Brand
GL - TAPERED WAFER (25)
Company
GREAT LAKES ORTHODONTICS, LTD.
Model
260-032
Catalog number
260-032
Device description
GL - TAPERED WAFER (25)
Published
2016-05-18
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
EGDWax, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7752600321PrimaryHIBCC0

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.

Sterilization Methods

Method

Contacts

PhoneEmail
800-828-7626info@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
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
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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