510(k) · Cleared
ClearedHigh Speed Air Turbine Handpiece, Models Super-Air and Super-QD Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peng Lim Enterprise Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Dec 14, 2006 as substantially equivalent to K052822 (Thunder Tiger Corp., 2006) after a 77-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 14, 2006
- Review
- 77 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935676 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 2 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 1 generation backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- This deviceK062947 High Speed Air Turbine Handpiece, Models Super-Air and Super-QD SeriesPeng Lim Enterprise Co., Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK071561 HI-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-DBeijing North Pole Dental Handpiece Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK093971 Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK080682 HHC, Score, Henry Schein Canister HandpieceHandpiece Headquarters, Inc. - Hpr, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K071561HI-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-DBeijing North Pole Dental Handpiece Co., Ltd. · 2007 · cites it directly1descendant
- K093971Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010 · 2 generations on0descendants
- K080682HHC, Score, Henry Schein Canister HandpieceHandpiece Headquarters, Inc. - Hpr, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −2 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −1 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| 0 (this device) | K062947 | High Speed Air Turbine Handpiece, Models Super-Air and Super-QD Series | Peng Lim Enterprise Co., Ltd. | 2006 | — |
| +1 | K071561 | HI-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D | Beijing North Pole Dental Handpiece Co., Ltd. | 2007 | — |
| +2 | K093971 | Dental Handpiece | North West Medical Instrument (Group) Co., Ltd. | 2010 | — |
| +1 | K080682 | HHC, Score, Henry Schein Canister Handpiece | Handpiece Headquarters, Inc. - Hpr, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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? (1)
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…models: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 51 OK No -K052822 * Statement of Intended Use: The PENG LIM High Speed Air Turbine Handpieces are intended for re… | 2006 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071561 (Beijing North Pole Dental Handpiece Co., Ltd., 2007) has gone furthest, with 1 descendant 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.
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?
PENG LIM High Speed Air Turbine Handpiece, models: Super-AIR and Super-QD series 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/K062947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062947: High Speed Air Turbine Handpiece, Models Super-Air and Super-QD Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062947
Report an extraction error
Are you the manufacturer?
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