FDA.reportPublic FDA data

SIMDA Abutment

Primary DI
08800137707160
Brand
SIMDA Abutment
Company
SIMDA CO.,LTD.
Model
TBMEM4323H
Catalog number
TBMEM4323H
Device description
Ti-Base
Published
2026-04-20
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232271000SIMDA abutmentSimda Co., Ltd.2023-10-26NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800137707160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800137707160088001377071608800137707160

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
(206) 438-3441info@blacksmithwave.com

Regulatory Flags#

DUNS number
694873150
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800137711259SIMDA AbutmentTBBIH3813HTBBIH3813H2026-04-21
08800137711266SIMDA AbutmentTBBIH3815HTBBIH3815H2026-04-21
08800137711273SIMDA AbutmentTBBIH3823HTBBIH3823H2026-04-21
08800137711280SIMDA AbutmentTBBIH3825HTBBIH3825H2026-04-21
08800137711297SIMDA AbutmentTBBIH3813NTBBIH3813N2026-04-21
08800137711303SIMDA AbutmentTBBIH3815NTBBIH3815N2026-04-21
08800137711310SIMDA AbutmentTBBIH3823NTBBIH3823N2026-04-21
08800137711327SIMDA AbutmentTBBIH3825NTBBIH3825N2026-04-21
08800137711334SIMDA AbutmentTBBIH4013HTBBIH4013H2026-04-21
08800137711341SIMDA AbutmentTBBIH4015HTBBIH4015H2026-04-21
08800137711358SIMDA AbutmentTBBIH4023HTBBIH4023H2026-04-21
08800137711365SIMDA AbutmentTBBIH4025HTBBIH4025H2026-04-21
08800137711372SIMDA AbutmentTBBIH4013NTBBIH4013N2026-04-21
08800137711389SIMDA AbutmentTBBIH4015NTBBIH4015N2026-04-21
08800137711396SIMDA AbutmentTBBIH4023NTBBIH4023N2026-04-21
08800137711402SIMDA AbutmentTBBIH4025NTBBIH4025N2026-04-21
08800137711419SIMDA AbutmentTBBIH4513HTBBIH4513H2026-04-21
08800137711426SIMDA AbutmentTBBIH4515HTBBIH4515H2026-04-21
08800137711433SIMDA AbutmentTBBIH4523HTBBIH4523H2026-04-21
08800137711440SIMDA AbutmentTBBIH4525HTBBIH4525H2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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