FDA.reportPublic FDA data

OVC Hybrid

Primary DI
09421031793685
Brand
OVC Hybrid
Company
RHONDIUM LIMITED
Model
OVC3 Hybrid FDI 14.15 L : USA 4-5 L A2
Catalog number
9421031793685
Device description
Package contains an OVC Hybrid in shade A2 for tooth number FDI 14.15 L : USA 4-5 L (Large), 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band, 1 x Hex Stick and 1 x OVC Replica.
Published
2017-09-15
Public version status
Update
Distribution status
Not 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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421031793685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421031793685094210317936859421031793685

GMDN Terms#

Term, Definition table
TermDefinition
Preformed dental crown, permanentA prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure (e.g. disposable prosthesis gauge).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-875-6246info@rhondium.com

Regulatory Flags#

DUNS number
595078345
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421031793616OVC Hybrid OVC3 Hybrid FDI 14.15 XS : USA 4-5 XS A394210317936162017-09-15
09421031793623OVC Hybrid OVC3 Hybrid FDI 14.15 XS : USA 4-5 XS A294210317936232017-09-15
09421031793630OVC Hybrid OVC3 Hybrid FDI 14.15 S : USA 4-5 S A394210317936302017-09-15
09421031793647OVC Hybrid OVC3 Hybrid FDI 14.15 S : USA 4-5 S A294210317936472017-09-15
09421031793654OVC Hybrid OVC3 Hybrid FDI 14.15 M : USA 4-5 M A394210317936542017-09-15
09421031793661OVC Hybrid OVC3 Hybrid FDI 14.15 M : USA 4-5 M A294210317936612017-09-15
09421031793678OVC Hybrid OVC3 Hybrid FDI 14.15 L : USA 4-5 L A394210317936782017-09-15
09421031793692OVC Hybrid OVC3 Hybrid FDI 14.15 XL : USA 4-5 XL A394210317936922017-09-15
09421031793708OVC Hybrid OVC3 Hybrid FDI 14.15 XL : USA 4-5 XL A294210317937082017-09-15
09421031793715OVC Hybrid OVC3 Hybrid FDI 16.17 XS : USA 2-3 XS A394210317937152017-09-15
09421031793722OVC Hybrid OVC3 Hybrid FDI 16.17 XS : USA 2-3 XS A294210317937222017-09-15
09421031793739OVC Hybrid OVC3 Hybrid FDI 16.17 S : USA 2-3 S A394210317937392017-09-15
09421031793746OVC Hybrid OVC3 Hybrid FDI 16.17 S : USA 2-3 S A294210317937462017-09-15
09421031793753OVC Hybrid OVC3 Hybrid FDI 16.17 M : USA 2-3 M A394210317937532017-09-15
09421031793760OVC Hybrid OVC3 Hybrid FDI 16.17 M : USA 2-3 M A294210317937602017-09-15
09421031793777OVC Hybrid OVC3 Hybrid FDI 16.17 L : USA 2-3 L A394210317937772017-09-15
09421031793784OVC Hybrid OVC3 Hybrid FDI 16.17 L : USA 2-3 L A294210317937842017-09-15
09421031793791OVC Hybrid OVC3 Hybrid FDI 16.17 XL : USA 2-3 XL A394210317937912017-09-15
09421031793807OVC Hybrid OVC3 Hybrid FDI 16.17 XL : USA 2-3 XL A294210317938072017-09-15
09421031793814OVC Hybrid OVC3 Hybrid FDI 24.25 XS: USA 12-13 XS A394210317938142017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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