FDA.report

PRO3DURE GR-16 Xray

Primary DI
EPRCD1001401
Brand
PRO3DURE GR-16 Xray
Company
pro3dure medical GmbH
Model
1kg - white-opaque
Device description
printodent GR-16 Xray
Published
2022-08-17
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
true

Related Records

Contact Domains

Product Codes

CodeName
DYTMaintainer, Space Preformed, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EPRCD1001401PrimaryHIBCC0

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
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+4923749200500info@pro3dure.com

Regulatory Flags

DUNS number
312947842
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
true
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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EPRCA0010200otosil IS-28 double cartridges of 2 x 25 mlA00102002023-10-18
EPRCA0011000otosil PS-12 x 300g ; Orange - WhiteA00110002023-10-18
EPRCA0034150otosil SL-1250 g - Clear Transparent A00341502023-10-18
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