FDA.report

CRS Set 10

Primary DI
E1996625131
Brand
CRS Set 10
Company
Candulor AG
Model
662513
Catalog number
662513
Device description
CRS Set 10
Published
2023-11-16
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
true

Related Records

Product Codes

CodeName
KCRFACEBOW

Product Code Classifications

CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E1996625131PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental articulatorA hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
480467422
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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07630813462219TCR Mono7562037562032025-05-20
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07630813439020Candulor Preference5784495784492023-11-16
07630813439075Candulor Preference5784445784442023-11-16
07630813439082Candulor Preference5784415784412023-11-16
07630813439136Candulor Preference5784365784362023-11-16
07630813439150Candulor Preference5784345784342023-11-16
07630813439167Candulor Preference5784335784332023-11-16
07630813439174Candulor Preference5784325784322023-11-16
07630813439204Candulor Preference5784295784292023-11-16
07630813439235Candulor Preference5784265784262023-11-16
07630813439242Candulor Preference5784235784232023-11-16
07630813439259Candulor Preference5784225784222023-11-16

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