FDA.reportPublic FDA data

TruBase S

Primary DI
08800076409156
Brand
TruBase S
Company
Truabutment Korea Co.,Ltd
Model
ZV3-B23S
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
K201197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201197000TruAbutment DS, TruBase STruabutment, Inc.2021-03-26NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076409156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076409156088000764091568800076409156

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694514760
Device count
1
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
08800076476356TruBite ScopeTBS2026-11-03
08800076476486TruBoltTB062026-11-03
08800076476493TruBoltTB082026-11-03
08800076476509TruBoltTB06082026-11-03
08800076476516TruBoltTB08082026-11-03
08800076424166T-L Titanium CapTLCTC54232026-04-08
08800076443785T-L Straight AbutmentUTLAN38102026-04-08
08800076443792T-L Straight AbutmentUTLAN38202026-04-08
08800076443808T-L Straight AbutmentUTLAN38302026-04-08
08800076443815T-L Straight AbutmentUTLAN38402026-04-08
08800076443822T-L Straight AbutmentUTLAN38502026-04-08
08800076443839T-L Straight AbutmentUTLAN38602026-04-08
08800076443846T-L Straight AbutmentUTLAR38102026-04-08
08800076443853T-L Straight AbutmentUTLAR38202026-04-08
08800076443860T-L Straight AbutmentUTLAR38302026-04-08
08800076443877T-L Straight AbutmentUTLAR38402026-04-08
08800076443884T-L Straight AbutmentUTLAR38502026-04-08
08800076443891T-L Straight AbutmentUTLAR38602026-04-08
08800076476226TruBoltTB0608(6)2026-07-21
08800076476233TruBoltTB0808(6)2026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968582008plant Implant System8dent Inc.NHA2026-11-04
088000968584398plant Implant System8dent Inc.NHA2026-11-04
088000968586998plant Implant System8dent Inc.NHA2026-11-04
088000968602108plant Implant System8dent Inc.NHA2026-11-04
088000968602278plant Implant System8dent Inc.NHA2026-11-04
088000968612318plant Implant System8dent Inc.NHA2026-11-04
088000968612488plant Implant System8dent Inc.NHA2026-11-04
088000968622908plant Implant System8dent Inc.NHA2026-11-04
088000968686058plant Implant System8dent Inc.NHA2026-11-04
088000968788578plant Implant System8dent Inc.NHA2026-11-04
00840481137181LOCATOR Angled AbutmentZest Anchors, LLCNHA2026-11-03
08800077020022ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020053ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020640ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020657ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020664ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020671ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020688ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020695ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020701ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020718ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020725ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020732ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020749ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020756ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020763ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020770ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020787ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020794ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020800ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30