FDA.report

FotoDent® IBT 385 nm

Primary DI
E239D351201
Brand
FotoDent® IBT 385 nm
Company
Dreve Dentamid GmbH
Model
D35120
Catalog number
D35120
Device description
No
Published
2019-11-26
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
false

Related Records

Contact Domains

Product Codes

CodeName
EBHMATERIAL, IMPRESSION TRAY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E239D351201PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic appliance positioning mould, basicA custom-made dental device in the form of an impression of a patient’s dentition intended to be used 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; appliances are added after the mould has been manufactured. It is made of synthetic polymer materials and is manufactured from an oral cavity impression or oral scan for a specific patient. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+49230388070info@dreve.de

Regulatory Flags

DUNS number
388000846
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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