510(k) Report

510(k) · Cleared

Cleared

A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea Handpiece Attachment

K070663510(k) AbbreviatedCleared Jul 5, 2007118-day reviewClass I21 CFR 872.4200

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

A-Dec, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Jul 5, 2007 after a 118-day review. The FDA summary names no predicate by number. 45 later devices descend from it.

Decided
Jul 5, 2007
Review
118 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
0

45 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2013: 2 descendants cleared2019: 2 descendants cleared2014: 3 descendants cleared2017: 5 descendants cleared2015: 4 descendants cleared2022: 4 descendants cleared2010: 1 descendant cleared2011: 2 descendants cleared2012: 2 descendants cleared2024: 6 descendants cleared2018: 2 descendants cleared2026: 3 descendants cleared2020: 3 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared20052010201520202025
  1. This deviceK070663 A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97…A-Dec, Inc. · 2007
  2. Descendant · cites it directly · 23 of its ownK073478 Supertorque High-Speed Handpieces and Gentlepower Handpieces and…Sybron Dental Specialties, Inc. · 2008
  3. Descendant · 2 generations on · 13 of its ownK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
  4. Descendant · 3 generations on · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
  5. Descendant · cites it directly · 6 of its ownK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017
  6. Descendant · cites it directly · 6 of its ownK133069 Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2014

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2008: 22010: 12011: 22012: 22013: 22014: 32015: 42017: 52018: 22019: 22020: 32021: 12022: 42023: 32024: 62026: 3
2008high 6 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 45 · See all
  • K073478Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSybron Dental Specialties, Inc. · 2008 · cites it directly23descendants
  • K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011 · 2 generations on13descendants
  • K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 3 generations on8descendants
  • K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017 · cites it directly6descendants
  • K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2014 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070663A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H…A-Dec, Inc.2007—
+1K073478Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSybron Dental Specialties, Inc.2008—
+2K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp.2011—
+3K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd.2015—
+1K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH2017—
+1K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201010
201120
201220
201320
201430
201540
201750
201820
201920
202030
202110
202240
202330
202460
202630
FIG. 1 — Lineage of K070663, 2007–2026Source: 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 EFB? 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 EFB device

  1. #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 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?

The FDA summary names no predicate by number.

What descends from it? (45)

See all 45

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

NumberDeviceApplicantDecidedDescendants
K073478Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSybron Dental Specialties, Inc.200823
K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH20176
K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.20146
K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH20194
K143465MASTERmatic LUXKaltenbach & Voigt GmbH20154
K080677Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co.20084
K121901TI-Max Z45Nakanishi, Inc.20130

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, K073478 (Sybron Dental Specialties, Inc., 2008) has gone furthest, with 23 descendants of its own.

How does its category compare?

All EFB devices

EFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · EFB

1in 2025

2007: 122008: 72009: 112010: 82011: 42012: 82013: 32014: 72015: 72016: 32017: 72018: 32019: 32020: 52021: 22022: 52023: 42024: 52025: 12026 (partial year): 4
2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

2007: 61 days median2008: 97 days median2009: 120 days median2010: 116 days median2011: 168 days median2012: 130 days median2013: 207 days median2014: 200 days median2015: 296 days median2016: 205 days median2017: 246 days median2018: 210 days median2019: 348 days median2020: 259 days median2022: 430 days median2023: 158 days median2024: 209 days median2026 (partial year): 252 days median
2007high 430 (2022) · low 61 (2007)2026

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

Recalls per year · EFB

No recall names EFB since 2007.

Adverse event reports per year · EFB

83in 2025

2007: 132008: 192009: 402010: 782011: 962012: 972013: 612014: 732015: 872016: 1222017: 1532018: 812019: 1172020: 942021: 1232022: 1572023: 1162024: 1042025: 83
2007high 157 (2022) · low 13 (2007)2025

MAUDE reports naming product code EFB, 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
20071261013
2008797019
200911120040
20108116078
20114168096
20128130097
20133207061
20147200073
20157296087
201632050122
201772460153
20183210081
201933480117
20205259094
20212—0123
202254300157
202341580116
202452090104
20251—083
202642520—

What is it indicated for?

The A-dec/W&H Synea Air-Driven Highspeed Handpiece is an air-powered dental handpiece for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

The A-dec/W&H Synea Handpiece Attachment is powered by either an air-motor or electric micromotor for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

Indications for use as stated in the FDA summary.

More from A-Dec, Inc.

69 FDA decisions under this applicant name. See the company

  • K213932A-dec 300, A-dec 500A-Dec, Inc. · 2022
  • K133776A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
  • K102234A-Dec 200 Dental SystemA-Dec, Inc. · 2010
  • K100647A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMA-Dec, Inc. · 2010
  • K082716A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment…A-Dec, Inc. · 2009

Recent decisions in EFB

The EFB category page

  • K260029Firstar Dental HandpiecesFDC Technology Industry Co. · 2026
  • K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
  • K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd. · 2026
  • K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB…Foshan Topmed Dental Co., Ltd. · 2026
  • K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbH · 2025

https://510kreport.com/device/K070663 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070663: A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea Handpiece Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070663

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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