FDA.reportPublic FDA data

Vulcan Custom Dental

Primary DI
00810033850899
Brand
Vulcan Custom Dental
Company
VULCAN CUSTOM DENTAL, INC
Model
PRINT004
Device description
Vulcan Progressive Line Surgical Guide
Published
2021-04-15
Public version status
New
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810033850899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810033850899008100338508998100338508990810033850899

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080285276
Device count
1
Premarket exempt
true
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

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Primary DI, Brand, Company table
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00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
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06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
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08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
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