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

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
00860016558908Unplastic RetainerAntiplastic, Inc.DYT2026-10-26
06909412314672Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314689Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314696Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314702Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314719Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314726Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314733Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314740Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314757Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314764Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314771Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314788Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314795Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314801Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314818Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06956748702659Angel AlignerWuxi EA Medical Instruments Technologies Limited.DYT2026-10-10
00850004223338ProMonitoringCANDID CARE CO.DYT2026-07-27
D9821716301LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716311LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716321LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716331LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716341LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716351LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716361LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716371LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
04260670160510dentona flexisplintdentona AGMQC2026-06-23
04260670160527dentona flexisplintdentona AGMQC2026-06-23
04260670160534dentona flexisplintdentona AGMQC2026-06-23
04260670160541dentona flexisplintdentona AGMQC2026-06-23