FDA.reportPublic FDA data

Hiflex Base Plates

Primary DI
D967130010
Brand
Hiflex Base Plates
Company
PREVEST DENPRO LIMITED
Model
1.3mm 10 upper and 10 lower
Catalog number
13001
Published
2022-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EEAPlate, Base, Shellac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEAPlate, Base, ShellacDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D967130010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental base plateA foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.

Regulatory Flags#

DUNS number
859546940
Device count
1
Premarket exempt
true
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
D967410010Rotoflex Gold files triangular cross section 21mm pack of six410012026-04-29
D967410020Rotoflex Gold files triangular cross section 25mm pack of six410022026-04-29
D967410030Rotoflex Gold files triangular cross section 31mm pack of six410032026-04-29
D967410040Rotoflex Gold files triangular cross section 17/0421mm pack of six410042026-04-29
D967410050Rotoflex Gold files triangular cross section 17/0425mm pack of six410052026-04-29
D967410060Rotoflex Gold files triangular cross section 20/0421mm pack of six410062026-04-29
D967410070Rotoflex Gold files triangular cross section 20/0425mm pack of six410072026-04-29
D967410080Rotoflex Gold files triangular cross section 25/0421mm pack of six410082026-04-29
D967410090Rotoflex Gold files triangular cross section 25/0425mm pack of six410092026-04-29
D967410100Rotoflex Gold files triangular cross section 30/0421mm pack of six410102026-04-29
D967410110Rotoflex Gold files triangular cross section 30/0425mm pack of six410112026-04-29
D967410120Rotoflex Gold files triangular cross section 35/0421mm pack of six410122026-04-29
D967410130Rotoflex Gold files triangular cross section 35/0425mm pack of six410132026-04-29
D967410140Rotoflex Gold files triangular cross section 40/0421mm pack of six410142026-04-29
D967410150Rotoflex Gold files triangular cross section 40/0425mm pack of six410152026-04-29
D967410160Rotoflex Gold files triangular cross section 20/0621mm pack of six410162026-04-29
D967410170Rotoflex Gold files triangular cross section 20/0625mm pack of six410172026-04-29
D967410180Rotoflex Gold files triangular cross section 25/0621mm pack of six410182026-04-29
D967410190Rotoflex Gold files triangular cross section 25/0625mm pack of six410192026-04-29
D967410200Rotoflex Gold files triangular cross section 30/0621mm pack of six410202026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412328068Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328075Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328082Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328099Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328105Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
E239D359501FotoDent® TryInDreve Dentamid GmbHEEA2026-02-27
04260635981594RS VIVO Try-InDeltaMed GmbHEEA2025-07-29
EDEL162112103Delta Try-In XTDeltaMed GmbHEEA2025-07-29
EPRC0220003ACRY PRINT RU-003 Try-Inpro3dure medical GmbHEEA2025-03-31
EPRC768485UCAN Print Try-Inpro3dure medical GmbHEEA2025-03-31
D161280200Axio-BaseAxiodent Inc.EEA2024-10-02
08720604633832Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
08720604633849Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
08720604633856Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
D040711820Veri DENT TryinWHIP-MIX CORPORATIONEEA2024-04-18
EPRCD1001651printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
EPRCD1001652printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
EPRCD1001653printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
00860010425411LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
00860010425428LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
00860010425435LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
EPRCD1001602PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-09-12
EPRCD1001603PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-09-12
EPRCD1001601PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-08-17
10850039704151Try-In 2Sprintray, Inc.EEA2022-02-28
04260635980207P pro Try-InDeltaMed GmbHEEA2022-02-11
04260635980542RS Try-InDeltaMed GmbHEEA2022-02-11
EDEL162111003Delta Try-InDeltaMed GmbHEEA2022-02-11
EDEL162112003Delta Try-InDeltaMed GmbHEEA2022-01-31
E22160491V-Print Try-InVOCO GmbHEEA2020-06-16