510(k) Report

510(k) · Cleared

Cleared

Mytis Arrow XXXX

K052254510(k) TraditionalCleared Jun 1, 2006287-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Brainbase Corporation · DZE Implant, Endosseous, Root-Form

Cleared on Jun 1, 2006 as substantially equivalent to K022562 (Nobel Biocare AB, 2002) and 3 other predicates after a 287-day review. Its family tree reaches back 4 generations to 1993.

Decided
Jun 1, 2006
Review
287 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K925765 (1993). 28 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors2000: 2 other ancestors2001: 2 other ancestors1999: 3 other ancestors1998: 2 other ancestors1997: 2 other ancestors1996: 4 other ancestors1995: 2 other ancestors1994: 2 other ancestors1988: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestorK925765 · Branemark System Standard 3.75MM Fixture · Nobelpharma USA, Inc. · 1993K994376 · Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA · Friadent GmbH · 2000K014235 · Osseotite NT Dental Implants & Accessories · Implant Innovations, Inc. · 2002K022009 · 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants · Implant Innovations, Inc. · 200219851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 13 other ancestors3 generations back: 8 other ancestors K022009 · 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants · Implant Innovations, Inc. · 2002K014235 · Osseotite NT Dental Implants & Accessories · Implant Innovations, Inc. · 2002K994376 · Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA · Friadent GmbH · 2000K925765 · Branemark System Standard 3.75MM Fixture · Nobelpharma USA, Inc. · 19930
  1. Root · 4 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
  2. 3 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
  3. 2 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
  4. 1 generation backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
  5. This deviceK052254 Mytis Arrow XXXXBrainbase Corporation · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K925765Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc.1993—
−3K994376Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2…Friadent GmbH2000—
−2K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002—
−1K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002—
0 (this device)K052254Mytis Arrow XXXXBrainbase Corporation2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199010
199420
199520
199640
199720
199820
199930
200020
200120
200220
FIG. 1 — Lineage of K052254, 1993–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K022562Various Branemark System Implants-Immediate Function Indication
Summary page 1
…e surgical procedures. Predicate Device The device is substantially equivalent to other legally marketed devices in the United States including Branemark Implants (K022562 & K993595) and 3i Dental Implant Systems (K022113 & K022009). Intended Use Mytis Implant Systems are intended for immediate plac…
Nobel Biocare AB2002—
*K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)
Summary page 1
…procedures. Predicate Device The device is substantially equivalent to other legally marketed devices in the United States including Branemark Implants (K022562 & K993595) and 3i Dental Implant Systems (K022113 & K022009). Intended Use Mytis Implant Systems are intended for immediate placement in p…
Nobel Biocare Uas, Inc.2000—
*K0221133I Dental Implant Accessories
Summary page 1
…device is substantially equivalent to other legally marketed devices in the United States including Branemark Implants (K022562 & K993595) and 3i Dental Implant Systems (K022113 & K022009). Intended Use Mytis Implant Systems are intended for immediate placement in partially or fully edentulous mandibles a…
Implant Innovations, Inc.2002—
*K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants
Summary page 1
…substantially equivalent to other legally marketed devices in the United States including Branemark Implants (K022562 & K993595) and 3i Dental Implant Systems (K022113 & K022009). Intended Use Mytis Implant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxilla…
Implant Innovations, Inc.2002—

Also cleared against K022562: 18 other devices →

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 13 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
  • 2 of the 28 ancestors have a recall of any class.
  • 18 other devices also cite its predicate K022562.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

Mytis Arrow XXXX systems are intended for immediate placement in extraction or surgically prepared sites in partially or fully edentulous mandibles and maxillae (type I or I1 bone), in support of single or multiple-unit restorations including; cement retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

Indications for use as stated in the FDA summary.

Also cleared against K022562

18 other devices cite the same predicate.

  • K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018
  • K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017
  • K142167Medentika Abutment SystemMedentika GmbH · 2015
  • K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L. · 2010
  • K073075Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsDentsply International, Inc. · 2008
  • K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007

More from Brainbase Corporation

3 FDA decisions under this applicant name. See the company

  • K083372Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009
  • K063236Beta-PowderBrainbase Corporation · 2007

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K052254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052254: Mytis Arrow XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052254

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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