FDA.reportPublic FDA data

Omnibut, Internal Hex 3.5, 3.8GH

Primary DI
D99038IH35OA0
Brand
Omnibut, Internal Hex 3.5, 3.8GH
Company
SMART DENTURE CONVERSIONS, LLC
Model
38IH35-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
D99038IH35OA0PrimaryHIBCC0

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
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
D99038IH45OA0Omnibut, Internal Hex 4.5, 3.8GH38IH45-OA2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020806819SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806826SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806833SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806871SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806888SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806895SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807113SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807120SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807137SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807144SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807274SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807281SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807298SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807304SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840684SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840691SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840707SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840714SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840769SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840776SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841124SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841131SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841148SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841155SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841162SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841179SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04