FDA.reportPublic FDA data

T-L Straight Abutment

Primary DI
08800076443877
Brand
T-L Straight Abutment
Company
Truabutment Korea Co.,Ltd
Model
UTLAR3840
Published
2026-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
true

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
K200817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200817000URIS OMNI Narrow System & ProstheticTruabutment, Inc.2020-10-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076443877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076443877088000764438778800076443877

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694514760
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
true
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
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
08800076443884T-L Straight AbutmentUTLAR38502026-04-08
08800076443891T-L Straight AbutmentUTLAR38602026-04-08
08800076476226TruBoltTB0608(6)2026-07-21
08800076476233TruBoltTB0808(6)2026-07-21
08800076474741TruBoltTB06(6)2026-03-17

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