510(k) · Cleared
ClearedPacemaker High-Speed Handpiece Model PM-MQ, PM-M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delma Medical Instrument (Guangzhou) Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Sep 9, 2010 as substantially equivalent to K052822 (Thunder Tiger Corp., 2006) and 5 other predicates after a 97-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Sep 9, 2010
- Review
- 97 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K935676 (1995). 10 ancestors in all, the oldest K760929 (1976). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 4 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 3 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 2 generations backK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
- 1 generation backK093084 Rolence Dental High Speed Handpiece, RHPRolence Ent., Inc. · 2009
- This deviceK101551 Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK112623 Airlight Dental HandpieceBeyes Dental Canada, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K112623Airlight Dental HandpieceBeyes Dental Canada, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −4 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −3 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −2 | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | Jindell Medical Instruments Co., Ltd. | 2006 | — |
| −1 | K093084 | Rolence Dental High Speed Handpiece, RHP | Rolence Ent., Inc. | 2009 | — |
| 0 (this device) | K101551 | Pacemaker High-Speed Handpiece Model PM-MQ, PM-M | Delma Medical Instrument (Guangzhou) Co., Ltd. | 2010 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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? (6)
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 1…al Device Class: 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 300T… | 2006 |
| * | K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300NSummary page 1…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 300T, TIGER 300K, TIGE R 300W, TIGER 300B3, TIGER 300N * K062740, JINDELL MEDI… | 2006 |
| * | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUSummary page 2…100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 * K062812, THUNGER TIGER CORP. TIGER 300T, TIGER 300K, TIGE R 300W, TIGER 300B3, TIGER 300N * K062740, JINDELL MEDICAL INSTRUMENTS CO., LTD. JINDELL HIGH SIPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU * K09… | 2006 |
| * | K093084 | Rolence Dental High Speed Handpiece, RHPSummary page 2…B3, TIGER 300N * K062740, JINDELL MEDICAL INSTRUMENTS CO., LTD. JINDELL HIGH SIPPED 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…D. JINDELL HIGH SIPPED 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 HAN DP… | 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 HAN DPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) Device Des… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112623 | Airlight Dental Handpiece | 2011 | 0 |
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 15 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K112623 (Beyes Dental Canada, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 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. 2010, 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?
PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are intended for removing carious material, reducing hard tooth structure, cavity prepardtion, finishing tooth preparations and restorations and polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101551: Pacemaker High-Speed Handpiece Model PM-MQ, PM-M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101551
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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