510(k) · Cleared
ClearedIntra-Lock Dental Implants with Blossom 3.4MM Implant Angled Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra-Lock International, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Aug 8, 2011 as substantially equivalent to K103194 (Intra-Lock International, Inc., 2011) after a 102-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Aug 8, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K925765 (1993). 68 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations between
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK072363 Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexBiomet 3i, Inc. · 2008
- 1 generation backK103194 Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc. · 2011
- This deviceK111199 Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc. · 2011
Show all 10 generations
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 9 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 8 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 7 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 6 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 5 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 4 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK072363 Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexBiomet 3i, Inc. · 2008
- 1 generation backK103194 Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc. · 2011
- This deviceK111199 Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −9 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −8 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −7 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −6 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −5 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −4 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K072363 | Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex | Biomet 3i, Inc. | 2008 | — |
| −1 | K103194 | Intra-Lock Dental Implants with Blossom | Intra-Lock International, Inc. | 2011 | — |
| 0 (this device) | K111199 | Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled Abutments | Intra-Lock International, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K103194 | Intra-Lock Dental Implants with BlossomSummary page 1…150 Angled Abutment Classification Name: Endosseous Dental Implant Abutment 21 CFR 872.3630 Predicate Devices: K103194, Intra-Lock Dental Implant System with Blossom Intended Use/indications: l… | 2011 |
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 18 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 8 of the 68 ancestors have a recall of any class.
- 3 other devices also cite its predicate K103194.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111199: Intra-Lock Dental Implants with Blossom 3.4MM 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/K111199
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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