510(k) Report

510(k) · Cleared

Cleared

DR Disposable Prophy Angle Model H310

K060377510(k) TraditionalCleared Apr 26, 200671-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 Resources · EGS Handpiece, Contra- And Right-Angle Attachment, Dental

Cleared on Apr 26, 2006 as substantially equivalent to K932990 (Oral-B Laboratories, 1993) after a 71-day review. Its family tree reaches back 1 generation to 1993.

Decided
Apr 26, 2006
Review
71 days
Class
Class I
Product code
EGS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K932990 (1993). No later device cites it as a predicate yet.

K932990 · Oral-B Disposable Prophy Angle W/Prophy Cup · Oral-B Laboratories · 19931990199520002005
K932990 · Oral-B Disposable Prophy Angle W/Prophy Cup · Oral-B Laboratories · 19930
  1. Root · 1 generation backK932990 Oral-B Disposable Prophy Angle W/Prophy CupOral-B Laboratories · 1993
  2. This deviceK060377 DR Disposable Prophy Angle Model H310Dental Resources · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K932990Oral-B Disposable Prophy Angle W/Prophy CupOral-B Laboratories1993—
0 (this device)K060377DR Disposable Prophy Angle Model H310Dental Resources2006—
FIG. 1 — Lineage of K060377, 1993–2006Source: 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 EGS? 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 EGS device

  1. #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K932990Oral-B Disposable Prophy Angle W/Prophy Cup
Summary page 1
…resident of Operations Telephone: 320.963.6267 Fax: 320.963.2029 Predicate Device: Oral-B Disposable Prophy' Angle W/Prophy Cup, K932990. Device Description: The DR Disposable Prophy Angle is a dental device that consists of a pair of gears, a turning spindle and a…
Oral-B Laboratories1993—

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?

  • Its one ancestor has no recall.

How does its category compare?

All EGS devices

EGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EGS

2in 2025

2007: 12009: 12010: 22011: 32012: 32013: 12014: 22015: 32017: 22018: 12019: 32020: 12021: 12022: 42023: 12024: 12025: 2
2007high 4 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EGS

189in 2022

2011: 104 days median2012: 288 days median2015: 245 days median2019: 276 days median2022: 189 days median
2007high 288 (2012) · low 104 (2011)2026

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

Recalls per year · EGS

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EGS

82in 2025

2007: 22008: 142009: 452010: 742011: 22012: 32013: 22014: 382015: 1662016: 2992017: 3162018: 2302019: 2192020: 1912021: 2942022: 2792023: 1152024: 812025: 82
2007high 316 (2017) · low 2 (2007)2025

MAUDE reports naming product code EGS, 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
20071—02
20080—014
20091—045
20102—074
2011310402
2012328803
20131—02
20142—038
201532450166
20160—0299
20172—0316
20181—0230
201932760219
20201—0191
20211—0294
202241890279
20231—1115
20241—081
20252—082
20260—0—

What is it indicated for?

The DR Disposable Prophy Angle is a device intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The DR Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination.

Indications for use as stated in the FDA summary.

Recent decisions in EGS

The EGS category page

  • K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) Limited · 2025
  • K240950Disposable Prophy AnglePacific Care Limited · 2025
  • K240183Star E900 Handpiece SeriesDentalez, Inc., Stardental Division · 2024
  • K230106General Cutting StraightNakanishi, Inc. · 2023
  • K222518FX ContraNakanishi, Inc. · 2022

https://510kreport.com/device/K060377 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060377: DR Disposable Prophy Angle Model H310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060377

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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