FDA.report

FotoDent® guide

Primary DI
E239D35600
Brand
FotoDent® guide
Company
Dreve Dentamid GmbH
Model
1
Catalog number
D35600
Device description
FotoDent® guide is a light-curing resin for the manufacturing of dental surgical drill guides using 405 nm-LED-based DLP® systems. For obligatory post curing of FotoDent® guide built parts, the high performance light curing unit FotoDent Flash®, PCU Evo and PCU 90 are recommended, which are optimal balanced to the manufacturing process.
Published
2016-10-28
Public version status
Update
Distribution status
Not 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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E239D35600PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental guided surgery reference plateA non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods

Method

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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