FDA.reportPublic FDA data

Vulcan Custom Dental

Primary DI
00810033850226
Brand
Vulcan Custom Dental
Company
VULCAN CUSTOM DENTAL, INC
Model
TIABUT114
Device description
BioHorizons Custom Titanium Healing Abutment, 5.7mm
Published
2019-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00810033850226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810033850226008100338502268100338502260810033850226

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
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
00810033851292Vulcan Custom DentalTIABUT1212024-06-17
00810033851308Vulcan Custom DentalTIABUT1222024-06-17
00810033851315Vulcan Custom DentalTIABUT1312024-06-17
00810033851322Vulcan Custom DentalTIABUT1322024-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873116SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873345SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873376SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874533SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874564SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874571SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874700SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874717SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874724SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874731SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874748SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874755SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874816SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874830SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08