510(k) · Cleared
ClearedBti Endosseous Dental Implant Angled Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.T.I. Biotechnology Institute, Sl. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 21, 2007 as substantially equivalent to K022258 (B.T.I. Biotechnology Institute, Sl., 2003) and 3 other predicates after a 115-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Jun 21, 2007
- Review
- 115 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K894595 (1990). 35 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 1 generation backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- This deviceK070533 Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −2 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −1 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| 0 (this device) | K070533 | Bti Endosseous Dental Implant Angled Abutments | B.T.I. Biotechnology Institute, Sl. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant SystemSummary page 1…d abutments are claimed to be substantially equivalents in material, design, and function to BTI Endosseous dental implant abutments cleared by FDA under 510 (k) K022258 on Sep 11, 2003 and 510 (k) 053355 on Mar 14, 2006 and in function and design to SFB & CFB Angled Abutments cleared by FD… | 2003 |
| * | K053355 | Bti Interna Dental Implant SystemSummary page 2…BSTANTIAL EQUIVALENCE The Endosseous dental implant angled abutments are considered to be substantially equivalent to the ease abutments previously cleared under K022258/K053355, K062749 and K994119. CONCLUSION The Endosseous dental implant angled abutments are considered to be substantially equivalent i… | 2006 |
| * | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Summary page 1…DA under 510 (k) K022258 on Sep 11, 2003 and 510 (k) 053355 on Mar 14, 2006 and in function and design to SFB & CFB Angled Abutments cleared by FDA under 510 (K) K062749 on Nov 29, 2006 and SynOcta® Angled Abutments cleared by FDA under 510 (K) K994119 on Mar 17, 2000.… | 2006 |
| * | K994119 | Synocta Angled AbutmentsSummary page 1…tion and design to SFB & CFB Angled Abutments cleared by FDA under 510 (K) K062749 on Nov 29, 2006 and SynOcta® Angled Abutments cleared by FDA under 510 (K) K994119 on Mar 17, 2000. Page 1 of 2 TRADITIONAL 510 (K) SUBMISSION Endosseous dental… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 35 ancestors have a recall of any class.
- 6 other devices also cite its predicate K022258.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Endosseous dental implant angled abutments are premanufactured prosthetic components directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation. They can be used in singled and multi-unit restorations where angled correction is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070533: Bti Endosseous Dental Implant Angled Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070533
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026