FDA.reportPublic FDA data

Vulcan Custom Dental

Primary DI
00810033850004
Brand
Vulcan Custom Dental
Company
VULCAN CUSTOM DENTAL, INC
Model
BAR101
Device description
BioHorizons Implant Bar 4+
Published
2019-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810033850004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810033850004008100338500048100338500040810033850004

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080285276
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810033850905Vulcan Custom DentalPRINT0052021-06-16
00810033850912Vulcan Custom DentalPRINT0062021-06-16
00810033850899Vulcan Custom DentalPRINT0042021-04-15
00810033850066Vulcan Custom DentalPRINT0032019-09-05
00810033851483Vulcan Custom Dental BAR2312026-02-19
00810033851476Vulcan Custom Dental TIABUT4322025-12-29
00810033851353Vulcan Custom DentalTIABUT3702024-07-30
00810033851360Vulcan Custom DentalTIABUT3712024-07-30
00810033851377Vulcan Custom DentalTIABUT3722024-07-30
00810033851384Vulcan Custom DentalTIABUT3802024-07-30
00810033851391Vulcan Custom DentalTIABUT3812024-07-30
00810033851407Vulcan Custom DentalTIABUT4502024-07-30
00810033851414Vulcan Custom DentalTIABUT4602024-07-30
00810033851421Vulcan Custom DentalTIABUT4702024-07-30
00810033851438Vulcan Custom DentalTIABUT4712024-07-30
00810033851445Vulcan Custom DentalTIABUT4722024-07-30
00810033851452Vulcan Custom DentalTIABUT4802024-07-30
00810033851469Vulcan Custom DentalTIABUT4812024-07-30
00810033851339Vulcan Custom DentalTIABUT3502024-07-29
00810033851346Vulcan Custom DentalTIABUT3602024-07-29

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Primary DI, Brand, Company table
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