FDA.reportPublic FDA data

Dental implant kit

Definition
A collection of prefabricated dental devices and components, which includes a dental implant, intended to be used during dental surgery and laboratory procedures to create and implant the foundation of a reconstructed tooth. In addition to the dental implant, it includes a dental abutment(s) (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), and additional components to facilitate restoration (e.g., abutment analog, abutment impression cap). This is a single-use device.
GUDID devices
254
Last updated
2026-07-30 21:31:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08800076476226TruBoltTruabutment Korea Co.,LtdTB0608(6)2026-07-21
08800076476233TruBoltTruabutment Korea Co.,LtdTB0808(6)2026-07-21
00887919584117Brasseler USAPeter Brasseler Holdings, LLC5014065U02022-12-08
18809931157581Kimplant KITHu Medi Tech Co., Ltd.KISK2026-04-21
00840481135408LOCATORZest Anchors, LLC075652026-05-22
00840481135972LOCATORZest Anchors, LLC075752026-05-22
00840481135989LOCATORZest Anchors, LLC075762026-05-22
00840481135996LOCATORZest Anchors, LLC079962026-05-22
00840481136009LOCATORZest Anchors, LLC079972026-05-22
08800076423756TruScan Post Kit CaseTruabutment Korea Co.,LtdBHN-SBCASE2026-03-24
08800076423763TruScan Post Kit CaseTruabutment Korea Co.,LtdBH35-SBCASE2026-03-24
08800076423770TruScan Post Kit CaseTruabutment Korea Co.,LtdBH45-SBCASE2026-03-24
08800076423787TruScan Post Kit CaseTruabutment Korea Co.,LtdBH57-SBCASE2026-03-24
08800076423794TruScan Post Kit CaseTruabutment Korea Co.,LtdDSU-SBCASE2026-03-24
08800076423800TruScan Post Kit CaseTruabutment Korea Co.,LtdAE30-SBCASE2026-03-24
08800076423817TruScan Post Kit CaseTruabutment Korea Co.,LtdAE36-SBCASE2026-03-24
08800076423824TruScan Post Kit CaseTruabutment Korea Co.,LtdAE42-SBCASE2026-03-24
08800076423831TruScan Post Kit CaseTruabutment Korea Co.,LtdAE48-SBCASE2026-03-24
08800076423848TruScan Post Kit CaseTruabutment Korea Co.,LtdAE54-SBCASE2026-03-24
08800076423855TruScan Post Kit CaseTruabutment Korea Co.,LtdAS4-SBCASE2026-03-24
08800076423862TruScan Post Kit CaseTruabutment Korea Co.,LtdAS5-SBCASE2026-03-24
08800076423879TruScan Post Kit CaseTruabutment Korea Co.,LtdOTM-SBCASE2026-03-24
08800076423886TruScan Post Kit CaseTruabutment Korea Co.,LtdOTR-SBCASE2026-03-24
08800076423893TruScan Post Kit CaseTruabutment Korea Co.,LtdMRD-SBCASE2026-03-24
08800076423909TruScan Post Kit CaseTruabutment Korea Co.,LtdNAN-SBCASE2026-03-24
08800076423916TruScan Post Kit CaseTruabutment Korea Co.,LtdNAR-SBCASE2026-03-24
08800076423923TruScan Post Kit CaseTruabutment Korea Co.,LtdNRN-SBCASE2026-03-24
08800076423930TruScan Post Kit CaseTruabutment Korea Co.,LtdNRR-SBCASE2026-03-24
08800076423947TruScan Post Kit CaseTruabutment Korea Co.,LtdNRW-SBCASE2026-03-24
08800076423954TruScan Post Kit CaseTruabutment Korea Co.,LtdNR6-SBCASE2026-03-24
08800076423961TruScan Post Kit CaseTruabutment Korea Co.,LtdSBN-SBCASE2026-03-24
08800076423978TruScan Post Kit CaseTruabutment Korea Co.,LtdSBR-SBCASE2026-03-24
08800076423985TruScan Post Kit CaseTruabutment Korea Co.,LtdSTR-SBCASE2026-03-24
08800076423992TruScan Post Kit CaseTruabutment Korea Co.,LtdSTW-SBCASE2026-03-24
08800076424005TruScan Post Kit CaseTruabutment Korea Co.,LtdBC34-SBCASE2026-03-24
08800076424012TruScan Post Kit CaseTruabutment Korea Co.,LtdBC41-SBCASE2026-03-24
08800076424029TruScan Post Kit CaseTruabutment Korea Co.,LtdBC50-SBCASE2026-03-24
08800076424036TruScan Post Kit CaseTruabutment Korea Co.,LtdZV3-SBCASE2026-03-24
08800076424043TruScan Post Kit CaseTruabutment Korea Co.,LtdZV4-SBCASE2026-03-24
08800076424050TruScan Post Kit CaseTruabutment Korea Co.,LtdZV5-SBCASE2026-03-24
08800076446632TruScan Post Kit CaseTruabutment Korea Co.,LtdDQR-SBCASE2026-03-24
08800076460843TruScan Post Kit CaseTruabutment Korea Co.,LtdNDG-SBCASE2026-03-24
08800076460850TruScan Post Kit CaseTruabutment Korea Co.,LtdSXR-SBCASE2026-03-24
08800076460867TruScan Post Kit CaseTruabutment Korea Co.,LtdSXW-SBCASE2026-03-24
08800076460881AOT Plus Scan BodyTruabutment Korea Co.,LtdAOTP-SSBH2026-03-24
08800076464186URIS Scan Post Kit CaseTruabutment Korea Co.,LtdUOM-SBCASE2026-03-24
08800076464193URIS Scan Post Kit CaseTruabutment Korea Co.,LtdUSP-SBCASE2026-03-24
08800076464568TruScan Post Kit CaseTruabutment Korea Co.,LtdZVN-SBCASE2026-03-24
08800076464575TruScan Post Kit CaseTruabutment Korea Co.,LtdNA3-SBCASE2026-03-24
08800076464582TruScan Post Kit CaseTruabutment Korea Co.,LtdSBS-SBCASE2026-03-24
08800076464711URIS Scan Body KitTruabutment Korea Co.,LtdUOM-PSBCASE2026-03-24
08800076473850TruScan Post Kit CaseTruabutment Korea Co.,LtdCN33-SBCASE2026-03-24
08800076473867TruScan Post Kit CaseTruabutment Korea Co.,LtdCN38-SBCASE2026-03-24
08800076473874TruScan Post Kit CaseTruabutment Korea Co.,LtdCN43-SBCASE2026-03-24
08800076473881TruScan Post Kit CaseTruabutment Korea Co.,LtdCN50-SBCASE2026-03-24
08800076474895URIS Scan Post Kit Truabutment Korea Co.,LtdUON-ALPHA2026-03-24
08800076474901URIS Scan Post Kit Truabutment Korea Co.,LtdUON-BETA2026-03-24
08800076474918URIS Scan Post Kit Truabutment Korea Co.,LtdUOR-ALPHA2026-03-24
08800076474925URIS Scan Post Kit Truabutment Korea Co.,LtdUOR-BETA2026-03-24
08800076474932URIS Scan Post Kit CaseTruabutment Korea Co.,LtdUSP-PSBCASE2026-03-24
08800076474741TruBoltTruabutment Korea Co.,LtdTB06(6)2026-03-17
08800076474758TruBoltTruabutment Korea Co.,LtdTB08(6)2026-03-17
08800076461642TruScan Body KitTruabutment Korea Co.,LtdBHN-PSBCASE2026-03-13
08800076461659TruScan Body KitTruabutment Korea Co.,LtdAE30-PSBCASE2026-03-13
08800076461666TruScan Body KitTruabutment Korea Co.,LtdOTM-PSBCASE2026-03-13
08800076461673TruScan Body KitTruabutment Korea Co.,LtdNDG-PSBCASE2026-03-13
08800076461680TruScan Body KitTruabutment Korea Co.,LtdNA3-PSBCASE2026-03-13
08800076461697TruScan Body KitTruabutment Korea Co.,LtdSBS-PSBCASE2026-03-13
08800076461703TruScan Body KitTruabutment Korea Co.,LtdZVN-PSBCASE2026-03-13
08800076465282TruScan Body KitTruabutment Korea Co.,LtdBHN-PSBCASE-JB2026-03-13
08800076465299TruScan Body KitTruabutment Korea Co.,LtdAE30-PSBCASE-JB2026-03-13
08800076465305TruScan Body KitTruabutment Korea Co.,LtdBC34-PSBCASE-JB2026-03-13
08800076465312TruScan Body KitTruabutment Korea Co.,LtdNA3-PSBCASE-JB2026-03-13
08800076465329TruScan Body KitTruabutment Korea Co.,LtdSBN-PSBCASE-JB2026-03-13
08800076465336TruScan Body KitTruabutment Korea Co.,LtdZVN-PSBCASE-JB2026-03-13
08800076465343TruScan Body KitTruabutment Korea Co.,LtdBHN-PSBCASE-VT2026-03-13
08800076465350TruScan Body KitTruabutment Korea Co.,LtdAE30-PSBCASE-VT2026-03-13
08800076465367TruScan Body KitTruabutment Korea Co.,LtdBC34-PSBCASE-VT2026-03-13
08800076465374TruScan Body KitTruabutment Korea Co.,LtdNA3-PSBCASE-VT2026-03-13
08800076465381TruScan Body KitTruabutment Korea Co.,LtdSBN-PSBCASE-VT2026-03-13