FDA.reportPublic FDA data

Megatray

Primary DI
EMD11MYDVOKS2
Brand
Megatray
Company
MEGADENTA Dentalprodukte GmbH
Model
2022/11/05
Device description
Light curing composite for the production of individual impression trays and base plates
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMD11MYDVOKBL1PackageHIBCC1In Commercial Distribution
EMD11MYDVOKRS1PackageHIBCC1In Commercial Distribution
EMD11MYDVOKRS11PackageHIBCC1In Commercial Distribution
EMD11MYDVOKTR1PackageHIBCC1In Commercial Distribution
EMD11MYDVOKS2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray materialA material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+4935284530info@megadenta.de

Regulatory Flags#

DUNS number
316153928
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EMD11MYDVOKRS1Megatray2022/11/052022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09
00840456214220JMUJMU DENTAL, INCEBH2026-07-09
00840456223680JMUJMU DENTAL, INCEBH2026-07-09
00840456223697JMUJMU DENTAL, INCEBH2026-07-09
00840456223703JMUJMU DENTAL, INCEBH2026-07-09
00840456223710JMUJMU DENTAL, INCEBH2026-07-09
00840456223727JMUJMU DENTAL, INCEBH2026-07-09
00840456223734JMUJMU DENTAL, INCEBH2026-07-09
00840456223741JMUJMU DENTAL, INCEBH2026-07-09