FDA.reportPublic FDA data

Omnibut, Neodent GM

Primary DI
D99023NEOGMOA0
Brand
Omnibut, Neodent GM
Company
SMART DENTURE CONVERSIONS, LLC
Model
23NEOGM-OA
Published
2025-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

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
D99023NEOGMOA0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8555500707contact@smartdentureconversions.com

Regulatory Flags#

DUNS number
010613514
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D990EK2A0Essentials Kit, 2 ArchEK2A2026-07-13
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GH25HMINI-OA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.425HMINI-OA1.42026-06-26
D99025HREGOA0Omnibut, Hiossen Regular, 2.5GH25HREG-OA2026-06-26
D99025HREGOA140Omnibut, Hiossen Regular, 2.5GH, M1.425HREG-OA1.42026-06-26
D99025MGAOA0Omnibut, MegaGen AnyRidge, 2.5GH25MGA-OA2026-06-26
D99025MGAOA140Omnibut, MegaGen AnyRidge, 2.5GH, M1.425MGA-OA1.42026-06-26
D99025TINT37OA0Omnibut, Tatum Integrity 3.7, 2.5GH25TINT37-OA2026-06-26
D99025TINT37OA140Omnibut, Tatum Integrity 3.7, 2.5GH, M1.425TINT37-OA1.42026-06-26
D99025TINT50OA0Omnibut, Tatum Integrity 5.0, 2.5GH25TINT50-OA2026-06-26
D99025TINT50OA140Omnibut, Tatum Integrity 5.0, 2.5GH, M1.425TINT50-OA1.42026-06-26
D99025TINT60OA0Omnibut, Tatum Integrity 6.0, 2.5GH25TINT60-OA2026-06-26
D99025TINT60OA140Omnibut, Tatum Integrity 6.0, 2.5GH, M1.425TINT60-OA1.42026-06-26
D99038BLXOA0Omnibut, Straumann BLX, 3.8GH38BLX-OA2026-06-26
D99038BLXOA140Omnibut, Straumann BLX, 3.8GH, M1.438BLX-OA1.42026-06-26
D99038HMINIOA0Omnibut, Hiossen Mini, 3.8GH38HMINI-OA2026-06-26
D99038HMINIOA140Omnibut, Hiossen Mini, 3.8GH, M1.438HMINI-OA1.42026-06-26
D99038HREGOA0Omnibut, Hiossen Regular, 3.8GH38HREG-OA2026-06-26
D99038HREGOA140Omnibut, Hiossen Regular, 3.8GH, M1.438HREG-OA1.42026-06-26
D99038IH35OA0Omnibut, Internal Hex 3.5, 3.8GH38IH35-OA2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710329Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710428prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710442prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710459prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710480Concave Hex. Healing Cap 6.mmCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710510prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710527prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710862prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710879prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710886prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710985prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711005prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711210Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711487Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711500Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711524Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711678Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712163prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712255prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712262prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
06009544052036N/ASOUTHERN IMPLANTS (PTY) LTDNHA2026-09-30
00840481138492LOCATOR, compatible with Nobel BiocareZest Anchors, LLCNHA2026-09-29
07290112780041Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780058Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780065MAGIX Dental Implant Ø4.2 L10mm PrimeCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780072Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780089Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780096Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780102Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780119Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29