FDA.reportPublic FDA data

Omnibut, Hiossen Mini, 3.8GH

Primary DI
D99038HMINIOA0
Brand
Omnibut, Hiossen Mini, 3.8GH
Company
SMART DENTURE CONVERSIONS, LLC
Model
38HMINI-OA
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
D99038HMINIOA0PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
D99038IH45OA0Omnibut, Internal Hex 4.5, 3.8GH38IH45-OA2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
08809917132710Healing Abutment SystemOsstem Implant Co., Ltd.NHA2026-07-29
08800070223673Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223710Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223758Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223796Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22