510(k) · Cleared
ClearedAirlight Dental Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beyes Dental Canada, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Dec 16, 2011 as substantially equivalent to K052822 (Thunder Tiger Corp., 2006) and 6 other predicates after a 99-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Dec 16, 2011
- Review
- 99 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K935676 (1995). 11 ancestors in all, the oldest K760929 (1976). No later device cites it as a predicate yet.
- Root · 6 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 5 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 4 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 3 generations backK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
- 2 generations backK093084 Rolence Dental High Speed Handpiece, RHPRolence Ent., Inc. · 2009
- 1 generation backK101551 Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010
- This deviceK112623 Airlight Dental HandpieceBeyes Dental Canada, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −5 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −4 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −3 | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | Jindell Medical Instruments Co., Ltd. | 2006 | — |
| −2 | K093084 | Rolence Dental High Speed Handpiece, RHP | Rolence Ent., Inc. | 2009 | — |
| −1 | K101551 | Pacemaker High-Speed Handpiece Model PM-MQ, PM-M | Delma Medical Instrument (Guangzhou) Co., Ltd. | 2010 | — |
| 0 (this device) | K112623 | Airlight Dental Handpiece | Beyes Dental Canada, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 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 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 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Summary page 2…I Classification Name: handpiece, air-powered, dental Regulation Number: 21 CFR 872.4200 Product Code: EFB Review Panel: Dental Predicate Device: * K052822, THUNGER TIGER CORP. TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 * K062812, THUNGER TIGER CORP. TIGER… | 2006 |
| * | K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300NSummary page 2…Code: EFB Review Panel: Dental Predicate Device: * K052822, THUNGER TIGER CORP. TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 * K062812, THUNGER TIGER CORP. TIGER 300T, TIGER 300K, TIGER 300W, TIGER 3008, TIGER 300N * K062740, JINDELL MEDICAL INSTRUMENTS… | 2006 |
| * | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUSummary page 2…. TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 * K062812, THUNGER TIGER CORP. TIGER 300T, TIGER 300K, TIGER 300W, TIGER 3008, TIGER 300N * K062740, JINDELL MEDICAL INSTRUMENTS CO., LTD. JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU * K0… | 2006 |
| * | K093084 | Rolence Dental High Speed Handpiece, RHPSummary page 2…00W, TIGER 3008, TIGER 300N * K062740, JINDELL MEDICAL INSTRUMENTS CO., LTD. JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU * K093084, ROLENCE ENT INC. ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP * K0631 10, SHANGHAI DENTAL INSTRUMENT FACTORY CST61… | 2009 |
| * | K063110 | CST61 High Speed Turbine HandpieceSummary page 2…. JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU * K093084, ROLENCE ENT INC. ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP * K0631 10, SHANGHAI DENTAL INSTRUMENT FACTORY CST61 HIGH SPEED TURBINE HANDPIECE * K021250, MK-DENT PUSH BUTTON HIGHSPEED HANDPI… | 2006 |
| * | K021250 | MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS…Summary page 2…3084, ROLENCE ENT INC. ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP * K0631 10, SHANGHAI DENTAL INSTRUMENT FACTORY CST61 HIGH SPEED TURBINE HANDPIECE * K021250, MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) * K1 0155… | 2002 |
| * | K101551 | Pacemaker High-Speed Handpiece Model PM-MQ, PM-MSummary page 2…T61 HIGH SPEED TURBINE HANDPIECE * K021250, MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) * K1 01551, DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. PACEMAKER HIGH-SPEED HANDPIECE, MODELS PM-MQ AND PM-M Device Description:… | 2010 |
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 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 11 ancestors has a recall.
- 5 other devices also cite its predicate K052822.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
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
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
Airlight Dental Handpiece Series, models M600 and M8OO are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112623: Airlight Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112623
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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