FDA.reportPublic FDA data

Orthocryl®

Primary DI
J011160000000
Brand
Orthocryl®
Company
DENTAURUM GmbH & Co.KG
Model
160-000-00
Device description
"Orthocryl® ""Neon"" Introductory Kit / orthodontic acrylics / For further information please visit our online-shop on our website www.dentaurum.de"
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMYPOSITIONER, TOOTH, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942667000DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.1995-02-13KMY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011160000000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic teeth positioner, preformedA prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep in a closed bottle/container - Protect from contamination and sunlight as they may cause premature polymerisation.

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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J011302208300tomas®302-208-302016-09-15
J011302210100tomas®302-210-102016-09-15
J011302210300tomas®302-210-302016-09-15
J011790261020equilibrium®790-261-022016-09-15
J011250001400ceraMotion®250-001-402016-09-15
J011250002200ceraMotion®250-002-202016-09-15
J011250002400ceraMotion®250-002-402016-09-15
J011250003200ceraMotion®250-003-202016-09-15
J011250003400ceraMotion®250-003-402016-09-15
J011250004200ceraMotion®250-004-202016-09-15
J011250004400ceraMotion®250-004-402016-09-15

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