510(k) Report

510(k) · Cleared

Cleared

Astra Tech Implants-Dental System

K931767510(k) TraditionalCleared Feb 8, 1994306-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

Astra Tech, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Feb 8, 1994 after a 306-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 573 later devices descend from it.

Decided
Feb 8, 1994
Review
306 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

573 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2006: 5 descendants cleared1998: 3 descendants cleared2012: 17 descendants cleared2016: 31 descendants cleared2003: 1 descendant cleared2005: 4 descendants cleared1999: 2 descendants cleared2001: 1 descendant cleared2010: 5 descendants cleared2009: 6 descendants cleared2007: 11 descendants cleared2004: 1 descendant cleared2013: 21 descendants cleared2015: 25 descendants cleared2022: 38 descendants cleared2024: 62 descendants cleared2020: 45 descendants cleared2014: 15 descendants cleared2019: 25 descendants cleared2017: 32 descendants cleared2021: 41 descendants cleared2018: 29 descendants cleared2002: 1 descendant cleared2011: 16 descendants cleared2008: 4 descendants cleared2023: 59 descendants cleared2026: 29 descendants cleared2025: 44 descendants cleared1990200020102020
  1. This deviceK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
  2. Descendant · cites it directly · 543 of its ownK974738 Astra Tech Implant Dental SystemAstra Tech, Inc. · 1998
  3. Descendant · cites it directly · 426 of its ownK991053 Astra Tech Implants - Dental System: New Fixtures (Micromacro)Astra Tech, Inc. · 1999
  4. Descendant · cites it directly · 424 of its ownK990304 Modification to Astra Tech Implant - Dental SystemAstra Tech, Inc. · 1999
  5. Descendant · cites it directly · 424 of its ownK980698 Astra Tech Implants - Dental SystemAstra Tech, Inc. · 1998
  6. Descendant · cites it directly · 423 of its ownK024111 Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc. · 2003

Showing 5 of 573 descendants. See all descendants

Descendants cleared per year

1998: 31999: 22001: 12002: 12003: 12004: 12005: 42006: 52007: 112008: 42009: 62010: 52011: 162012: 172013: 212014: 152015: 252016: 312017: 322018: 292019: 252020: 452021: 412022: 382023: 592024: 622025: 442026: 29
1998high 62 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 573 · See all
  • K974738Astra Tech Implant Dental SystemAstra Tech, Inc. · 1998 · cites it directly543descendants
  • K991053Astra Tech Implants - Dental System: New Fixtures (Micromacro)Astra Tech, Inc. · 1999 · cites it directly426descendants
  • K990304Modification to Astra Tech Implant - Dental SystemAstra Tech, Inc. · 1999 · cites it directly424descendants
  • K980698Astra Tech Implants - Dental SystemAstra Tech, Inc. · 1998 · cites it directly424descendants
  • K024111Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc. · 2003 · cites it directly423descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931767Astra Tech Implants-Dental SystemAstra Tech, Inc.1994—
+1K974738Astra Tech Implant Dental SystemAstra Tech, Inc.1998—
+1K991053Astra Tech Implants - Dental System: New Fixtures (Micromacro)Astra Tech, Inc.1999—
+1K990304Modification to Astra Tech Implant - Dental SystemAstra Tech, Inc.1999—
+1K980698Astra Tech Implants - Dental SystemAstra Tech, Inc.1998—
+1K024111Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199830
199920
200110
200210
200310
200410
200540
200650
2007110
200840
200960
201050
2011160
2012170
2013210
2014150
2015250
2016310
2017320
2018290
2019250
2020450
2021410
2022380
2023590
2024620
2025440
2026290
FIG. 1 — Lineage of K931767, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (573)

See all 573

13 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974738Astra Tech Implant Dental SystemAstra Tech, Inc.1998543
K991053Astra Tech Implants - Dental System: New Fixtures (Micromacro)Astra Tech, Inc.1999426
K990304Modification to Astra Tech Implant - Dental SystemAstra Tech, Inc.1999424
K980698Astra Tech Implants - Dental SystemAstra Tech, Inc.1998424
K024111Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc.2003423
K120414Osseospeed PlusAstra Tech AB2012196
K043195Neo Implant SystemNeoss, Ltd.2005167
K052957Implantium ProstheticsDentium Co., Ltd.200678
K100993Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsPrismatik Dentalcraft, Inc.201033
K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165

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?

  • Of its descendants, K974738 (Astra Tech, Inc., 1998) has gone furthest, with 543 descendants of its own.

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—

More from Astra Tech, Inc.

28 FDA decisions under this applicant name. See the company

  • K122078Lofric Primo, Lofric Hydro-KitAstra Tech, Inc. · 20123 recalls
  • K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc. · 2012
  • K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant, Atlantis Gemini (TM)…Astra Tech, Inc. · 2012
  • K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
  • K110640Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later AbutmentAstra Tech, Inc. · 2011

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/K931767 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931767: Astra Tech Implants-Dental System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931767

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026