510(k) · Cleared

Cleared

Clearview Dental Handpiece Lubricator and Lubricant

K070297510(k) TraditionalCleared Feb 5, 20075-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

Dental Air Solutions of Nc, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Feb 5, 2007 as substantially equivalent to K010127 (A-Dec, Inc., 2001) and 1 other predicate after a 5-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Feb 5, 2007
Review: 5 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K954991 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK954991 Phase Change Dental LubricantPhase Change · 1996
This deviceK070297 Clearview Dental Handpiece Lubricator and LubricantDental Air Solutions of Nc, Inc. · 2007
Descendant · cites it directly · 0 of its ownK073353 DO-All Dental Handpiece LubricantProdrive Systems, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K073353DO-All Dental Handpiece LubricantProdrive Systems, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954991	Phase Change Dental Lubricant	Phase Change	1996	—
0 (this device)	K070297	Clearview Dental Handpiece Lubricator and Lubricant	Dental Air Solutions of Nc, Inc.	2007	—
+1	K073353	DO-All Dental Handpiece Lubricant	Prodrive Systems, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K070297, 1996–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K010127	W & H Assistina Summary page 2 …ricator and Lubricant is substantially equivalent to the following predicate devices: a. Predicate for Lubricator: W & H Assistina, 510(k) K010127 b. Predicate for Lubricant: a Phase Change Dental Lubricant, 510(k) K954991 4. Device Description:…	A-Dec, Inc.	2001	—
*	K954991	Phase Change Dental Lubricant Summary page 2 …a. Predicate for Lubricator: W & H Assistina, 510(k) K010127 b. Predicate for Lubricant: a Phase Change Dental Lubricant, 510(k) K954991 4. Device Description: Lubricator: This information is detailed on the manufacturing drawings and photogra…	Phase Change	1996	—

Also cleared against K010127: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073353	DO-All Dental Handpiece Lubricant	Prodrive Systems, Inc.	2007	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?

None of the 2 ancestors has a recall.
Of its descendants, K073353 (Prodrive Systems, Inc., 2007) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K010127.

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

2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	12	61	13
2008	7	97	19
2009	11	120	40
2010	8	116	78
2011	4	168	96
2012	8	130	97
2013	3	207	61
2014	7	200	73
2015	7	296	87
2016	3	205	122
2017	7	246	153
2018	3	210	81
2019	3	348	117
2020	5	259	94
2021	2	—	123
2022	5	430	157
2023	4	158	116
2024	5	209	104
2025	1	—	83
2026	4	252	—

What is it indicated for?

The ClearViewTM Handpiece Lubricator is used for the delivery of ClearViewTM Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070297 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070297: Clearview Dental Handpiece Lubricator and Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070297

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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