FDA.reportPublic FDA data

printodent GR-19.1 OA I MSI

Primary DI
EPRCD1001504
Brand
printodent GR-19.1 OA I MSI
Company
pro3dure medical GmbH
Model
ocean-blue, 1000g
Catalog number
D1001504
Published
2023-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYTMaintainer, Space Preformed, Orthodontic
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231775000GR Resin System MSIPro3Dure Medical2024-08-08MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPRCD1001504PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental occlusal splint, custom-madeA rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). This is a reusable device.

Sterilization Methods#

Method table
Method

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
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
EPRCA0034150otosil SL-1250 g - Clear Transparent A00341502023-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260670160510dentona flexisplintdentona AGMQC2026-06-23
04260670160527dentona flexisplintdentona AGMQC2026-06-23
04260670160534dentona flexisplintdentona AGMQC2026-06-23
04260670160541dentona flexisplintdentona AGMQC2026-06-23
04260670160558dentona flexisplintdentona AGMQC2026-06-23
04260670160572dentona flexisplintdentona AGMQC2026-06-23
04260670160589dentona flexisplintdentona AGMQC2026-06-23
04260670160596dentona vivatempdentona AGMQC2026-06-23
04260670160602dentona vivatempdentona AGMQC2026-06-23
04260670160619dentona vivatempdentona AGMQC2026-06-23
04260670160626dentona vivatempdentona AGMQC2026-06-23
04260670160633dentona vivatempdentona AGMQC2026-06-23
04260670160640dentona vivatempdentona AGMQC2026-06-23
04260670160657dentona vivatempdentona AGMQC2026-06-23
04260670160688optimill memosplintdentona AGMQC2026-06-23
04260670160695optimill memosplintdentona AGMQC2026-06-23
04260670160701optimill memosplintdentona AGMQC2026-06-23
04260670160718optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160725optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160732optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160749optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160756optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160664optimill memosplintdentona AGMQC2026-06-22
04260670160671optimill memosplintdentona AGMQC2026-06-22
00815967026112RodinPac-Dent, Inc.MQC2026-05-20
D175H3DMTA91MemoryTech AlignersHype Align Clear Orthodontics LimitadaDYT2026-02-10
00816063023777Invisalign Specifix Attachment SystemAlign Technology, Inc.DYT2026-02-09
00816063023784lnvisalign Specifix Attachment System (include Engagement Features)Align Technology, Inc.DYT2026-02-09
00190730084583Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
00190730084590Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24