510(k) · Cleared
ClearedBT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and Dddiiibtisi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Btlock Srl · DZE Implant, Endosseous, Root-Form
Cleared on Mar 27, 2009 as substantially equivalent to K073458 (Btlock Srl, 2008) and 3 other predicates after an 88-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Mar 27, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K925765 (1993). 91 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK073458 BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl · 2008
- This deviceK083869 BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S)…Btlock Srl · 2009
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK073458 BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl · 2008
- This deviceK083869 BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S)…Btlock Srl · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K073458 | BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2) | Btlock Srl | 2008 | — |
| 0 (this device) | K083869 | BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3… | Btlock Srl | 2009 | — |
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 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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 |
|---|---|---|---|
| * | K073458 | BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Summary page 2…/---^ S-6 The major part of the products you see in the catalogue have already been approved by the FDA with the K073458. We registered recently at FURLS. This is our owner operator number: 10027925. BTLock system is already registered as medical dev… | 2008 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 4…Mini Implant BTLock device Reference Device name Manufacturer Mini Implant K031106 MDI Imtec Sendac Description of the device The fixture of the mini implant line… | 2003 |
| * | K031345 | Nobel Direct, Models 30937, 30938Summary page 5…Mini Single BTLock device Reference Device name Manufacturer Mini Single K031345 Nobel Direct 3.0 Nobel Biocare Description of the device It is a self-threaded and tapered im… | 2003 |
| * | K052471 | HDC Spider ScrewSummary page 6…6 BTLock device Reference Device name Manufacturer Slot Implant K052471 Spider Screw HDC S.r.l. Description of the device This device is made of titanium alloy,… | 2005 |
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 16 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 10 of the 91 ancestors have a recall of any class.
- 1 other device also cites its predicate K073458.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
BT-Tite CV3: It is intended to be used in maxilla or mandible, for post-extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. Mini Implant: It is intended to be used in maxilla or mandible for immediate and long-term stabilization of removable prosthesis. Mini Single: It is intended to be used in maxilla or mandible in anterior narrow sites of dental arch, to…
Read the full statement (161 words)
BT-Tite CV3: It is intended to be used in maxilla or mandible, for post-extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure.
Mini Implant: It is intended to be used in maxilla or mandible for immediate and long-term stabilization of removable prosthesis.
Mini Single: It is intended to be used in maxilla or mandible in anterior narrow sites of dental arch, to replace lateral teeth, dental agenesis and inferior incisors.
Slot implant: It is intended to be used as temporary intra-oral anchorage unit in the orthodontic treatment in the superior or inferior arch or extra arch in case of edentulous patients, when necessary teeth for the anchorage are absent or the next teeth are compromised from a parodontal point of view. It facilitates the orthodontic movement of teeth. It is removed after orthodontic treatment has been completed. Slot implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083869: BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and Dddiiibtisi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083869
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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