FDA.report

vynacron dental resins

Primary DI
00858801007311
Brand
vynacron dental resins
Company
VYNACRON DENTAL RESINS INC
Model
5HPOR
Device description
denture resin
Published
2017-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00858801007311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00858801007311008588010073118588010073110858801007311

GMDN Terms

TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080952401
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00858801007007vynacron dental resins1VP2017-08-08
00858801007014vynacron dental resins5VP2017-08-08
00858801007021vynacron dental resins25VP2017-08-08
00858801007038vynacron dental resins1PTVPM2017-08-08
00858801007045vynacron dental resins1QTVPM2017-08-08
00858801007052vynacron dental resins1GAVPM2017-08-08
00858801007069vynacron dental resins1VR902017-08-08
00858801007076vynacron dental resins5VR902017-08-08
00858801007083vynacron dental resins25VR902017-08-08
00858801007090vynacron dental resins1PTVR90M2017-08-08
00858801007106vynacron dental resins1QTVR90M2017-08-08
00858801007113vynacron dental resins1GAVR90M2017-08-08
00858801007120vynacron dental resins1HPAC2017-08-08
00858801007137vynacron dental resins5HPAC2017-08-08
00858801007144vynacron dental resins25HPAC2017-08-08
00858801007151vynacron dental resins1PTHPACM2017-08-08
00858801007168vynacron dental resins1QTHPACM2017-08-08
00858801007175vynacron dental resins1GAHPACM2017-08-08
00858801007182vynacron dental resins1VCA2017-08-08
00858801007199vynacron dental resins5VCA2017-08-08

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