FDA.report

Automark Non-Adjustable Articulator

Primary DI
D04011040741
Brand
Automark Non-Adjustable Articulator
Company
WHIP-MIX CORPORATION
Model
110407-4
Catalog number
110407-4
Device description
A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosis, or to construct dental appliances. This is a reusable device.
Published
2020-09-22
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

Product Codes

CodeName
EJPArticulators

Product Code Classifications

CodeDeviceSpecialtyClass
EJPArticulatorsDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D04011040741PrimaryHIBCC0

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

Regulatory Flags

DUNS number
006385173
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
false

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