FDA.report

Primeprint Ortho

Primary DI
EDET027851
Brand
Primeprint Ortho
Company
DETAX GmbH & Co. KG
Model
02785
Published
2022-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDET027851PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic appliance positioning tray, basicA custom-made dental device in the form of a patient’s dentition with slots/sockets intended to position and hold in place a set of orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure; the orthodontic appliances are loaded onto the device by the orthodontist prior to the procedure. Also known as an indirect bonding tray, it is typically made of synthetic polymer materials and is manufactured from an oral cavity impression or oral scan for a specific patient. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
317099257
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
EDET021651detax Impression lacquer 1000 ml021652022-10-26
EDET025891detax Impression lacquer 30 ml025892022-10-26
EDET041641medicalprint shell blue opaque 1000g041642022-10-26
EDET041651medicalprint shell red opaque 1000g041652022-10-26
EDET042301detax softwear 2.0 clear 40 shore 8x 50 ml042302022-10-26
EDET042381detax softwear 2.0 blue 60 shore 2 x 50 ml042382022-10-26
EDET042461luxaprint flex UV 500 g 042462022-10-26
EDET027231aquaplus putty blue 2 x 250 ml027232022-10-25
EDET027241aquaplus putty red 2 x 250 ml027242022-10-25
EDET029411protect mold neon pink 2 x 100ml029412022-10-25
EDET029461protect mold neon green 2 x 100ml029462022-10-25
EDET029471protect mold neon green 2 x 100ml029472022-10-25
EDET029481protect mold neon orange 2 x 100ml029482022-10-25
EDET029491super coat 100ml029492022-10-25
EDET029501super coat 300ml029502022-10-25
EDET029911earflex 40 sh rainbow 8 x 50 ml029912022-10-25
EDET030121express coat 100ml030122022-10-25
EDET030141dip coat 100ml030142022-10-25
EDET030151dip coat 250ml030152022-10-25
EDET031921earflex 40 sh clear 8 x 50 ml031922022-10-25

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