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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011130131000N.A.130-131-002020-08-28
J011130137000N.A.130-137-002020-08-28
J011130138000N.A.130-138-002020-08-28
J011130324000N.A.130-324-002020-08-28
J011130634000N.A.130-634-002020-08-28
J011262411100Carmen®262-411-102016-09-15
J011262412100Carmen®262-412-102016-09-15
J011262415100Carmen®262-415-102016-09-15
J011262421100Carmen®262-421-102016-09-15
J011262422100Carmen®262-422-102016-09-15
J011262423100Carmen®262-423-102016-09-15
J011262424100Carmen®262-424-102016-09-15
J011262431100Carmen®262-431-102016-09-15
J011262432100Carmen®262-432-102016-09-15
J011262433100Carmen®262-433-102016-09-15
J011262434100Carmen®262-434-102016-09-15
J011262442100Carmen®262-442-102016-09-15
J011262443100Carmen®262-443-102016-09-15
J011262444100Carmen®262-444-102016-09-15
J011262450100Carmen®262-450-102016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054154160013EQUILIBRATORE 1.0EPTAMED SRLKMY2026-07-28
08054154160020EQUILIBRATORE 1.05EPTAMED SRLKMY2026-07-28
08054154160037EQUILIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154160051EQUILIBRATORE 1.2 YOUNGEPTAMED SRLKMY2026-07-28
08054154160143EQUILIBRATORE 3.2EPTAMED SRLKMY2026-07-28
08054154160150EQULIBRATORE 3.3EPTAMED SRLKMY2026-07-28
08054154160198EquiIlibratore C2EPTAMED SRLKMY2026-07-28
08054154160204Equilibratore C3EPTAMED SRLKMY2026-07-28
08054154160211Equilibratore C4EPTAMED SRLKMY2026-07-28
08054154160228EQUILIBRATORE C3PEPTAMED SRLKMY2026-07-28
08054154160259EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160266EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160273EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160297FREEDOMEPTAMED SRLKMY2026-07-28
08054154160303EQUILIBRATORE GENIUS 3EPTAMED SRLKMY2026-07-28
08054154160334EQUILIBRATORE NIKI 1EPTAMED SRLKMY2026-07-28
08054154160372EQUILIBRATORE 003EPTAMED SRLKMY2026-07-28
08054154160402EQUILIBRATORE SL3 YOUNGEPTAMED SRLKMY2026-07-28
08054154160426EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160433EQUILIBRATORE U4EPTAMED SRLKMY2026-07-28
08054154160501EQULIBRATORE U2EPTAMED SRLKMY2026-07-28
08054154160563EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160761EQUILIBRATORE NIKI 2EPTAMED SRLKMY2026-07-28
08054154160815EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160822EQUILIBRATORE GENIUS 2EPTAMED SRLKMY2026-07-28
08054154160945EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160969EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154161089EQULIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154161126EQUILIBRATORE C3P YOUNGEPTAMED SRLKMY2026-07-28
08054154161164EQULIBRATORE U4 YOUNGEPTAMED SRLKMY2026-07-28