FDA.reportPublic FDA data

SICAT OPTIMOTION

Primary DI
D776105010
Brand
SICAT OPTIMOTION
Company
SiCAT GmbH & Co. KG
Model
10501
Catalog number
10501
Device description
SICAT OPTIMOTION
Published
2022-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143655000SICAT OPTIMOTIONSicat GmbH & Co. KG2015-10-02MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D776105010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49286206600support@sicat.com

Regulatory Flags#

DUNS number
333707003
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D776SBPV100SICAT Bite Plate10300100103001002024-02-26
D776103000SICAT Bite Plate (Kit)10300103002023-06-13
D776AIRV20400SICAT Air 2.0.402022-01-12
D776ENDOV20400SICAT ENDOV2.0.402022-01-12
D776FUNCTIONV20400SICAT FUNCTIONV2.0.402022-01-12
D776IMPLANTV20400SICAT IMPLANTV2.0.402022-01-12
D77666224630SICAT Endo662246366224632018-04-09
D776AIRV200SICAT Air 2.02019-08-19
D776GIV1920GALILEOS Implant1.9.261432052019-08-07
D776ENDOV200SICAT ENDOV2.02019-12-12
D776FUNCTIONV200SICAT FUNCTIONV2.02019-12-12
D776IMPLANTV150SICAT IMPLANTV1.52019-12-12
D776IMPLANTV200SICAT IMPLANTV2.02019-12-12
D776SUITEV200SICAT SUITEV2.02019-12-12
D776IMPLANTV15SICAT ImplantV1.52019-09-17
D776ENDOV20SICAT ENDOV2.02019-09-08
D776FUNCTIONV20SICAT FUNCTIONV2.02019-09-08
D776SUITEV20SICAT SUITEV2.02019-09-08
D776OSLEEPV110SICAT OPTISLEEPV1.1104012023-08-03
D776OSLEEPV11SICAT OPTISLEEPV1.1104012022-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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