FDA.reportPublic FDA data

CORiTEC Splint Comfort

Primary DI
01111111111116
Brand
CORiTEC Splint Comfort
Company
pro3dure medical GmbH
Model
clear transparent, height 16 mm
Catalog number
PEMCR00016
Device description
CORiTEC disc, diameter 98.5 mm, height 16 mm
Published
2022-09-02
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
K212017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212017000Thermeo SystemPro3Dure Medical GmbH2022-04-08MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01111111111116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01111111111116011111111111161111111111116

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
+4923749200500info@pro3dure.com

Regulatory Flags#

DUNS number
312947842
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EPRCD1001501printodent GR-19.1 OAclear-transparent, 1000gD10015012023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIocean-blue, 1000gD10015042023-08-29
EPRC66100851dima Print Denture Base 21kg - Pink661008512025-07-31
EPRC66100849dima Print Denture Base 21kg - Original Pink661008492025-07-31
EPRC66100850dima Print Denture Base 21kg - Reddish-Pink661008502025-07-31
EPRC0220001A2ACRY PRINT RU-001 Temporary1000g ; A20220001A22025-03-31
EPRC0220001A3ACRY PRINT RU-001 Temporary1000g ; A30220001A32025-03-31
EPRC0220003ACRY PRINT RU-003 Try-In1000g ; A202200032025-03-31
EPRC0220004ACRY PRINT RU-004 Denture HI1000g ; Orange-Pink02200042025-03-31
EPRC0220005ACRY PRINT RU-005 Guide1000g ; Clear-Transparent02200052025-03-31
EPRC768345UCAN Print Base1000g ; color 337683452025-03-31
EPRC768485UCAN Print Try-In1000g ; A27684852025-03-31
EPRC768486UCAN Print Splint1000g ; Transparent7684862025-03-31
EPRC768507UCAN Print Tray1000g ; Light-Pink7685072025-03-31
EPRC6550IMPRIMO LC Splint comfortclear-transparent, 1000g65502024-05-06
EPRC6575IMPRIMO LC Splint comfort MSIocean-blue, 1000g65752024-05-06
EPRCD1000300PRO3DURE GR-1guide1kg - clear-transparent 2022-08-17
EPRCD1000808printodent GR-10 guide I MSI 1000g ; ocean-blueD10008082024-08-20
EPRCA0010200otosil IS-28 double cartridges of 2 x 25 mlA00102002023-10-18
EPRCA0011000otosil PS-12 x 300g ; Orange - WhiteA00110002023-10-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H66842000141KeyPrintKeystone IndustriesMQC2024-09-26
H66841101411KeyPrintKeystone IndustriesMQC2023-09-25
H66842201511KeyPrintKeystone IndustriesMQC2023-09-25
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
D745701164RSN00070Glidewell TuffSplint™ Appliance ResinPrismatik Dentalcraft, IncMQC2023-04-11
00810002220241The Luco Hybrid OSA ApplianceJOHN'S DENTAL LABORATORY INCMQC2023-03-28
H66842000111KeyPrintKeystone IndustriesMQC2023-02-20
H66842001611KeyPrintKeystone IndustriesMQC2023-02-20
H66842200111KeyPrintKeystone IndustriesMQC2023-02-20
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H66842201611KeyPrintKeystone IndustriesMQC2023-02-20
H66850524011Nexa3DKeystone IndustriesMQC2023-02-20
H66852233011Nexa3DKeystone IndustriesMQC2023-02-20
H668D6400231PearsonKeystone IndustriesMQC2023-02-20
H668D6400241PearsonKeystone IndustriesMQC2023-02-20
H668D6400271PearsonKeystone IndustriesMQC2023-02-20
H668210041American DentalKeystone IndustriesMQC2022-11-30
H668210051American DentalKeystone IndustriesMQC2022-11-30
H668210061American DentalKeystone IndustriesMQC2022-11-30
H66870001901ProformKeystone IndustriesMQC2022-11-30
H6687000190R11ProformKeystone IndustriesMQC2022-11-30
H6687000190R21ProformKeystone IndustriesMQC2022-11-30
H66870001911ProformKeystone IndustriesMQC2022-11-30
H6687000191R11ProformKeystone IndustriesMQC2022-11-30
H6687000191R21ProformKeystone IndustriesMQC2022-11-30
H66870001921ProformKeystone IndustriesMQC2022-11-30