510(k) Report

510(k) · Cleared

Cleared

Beach Amalgam Carver

K821785510(k) TraditionalCleared Jul 6, 198219-day reviewClass I21 CFR 872.4565

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pacific Dental Corp. · EKH Carver, Dental Amalgam, Operative

Cleared on Jul 6, 1982 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 6, 1982
Review
19 days
Class
Class I
Product code
EKH
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K821785Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EKH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All EKH devices

EKH Carver, Dental Amalgam, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKH

FDA has decided no EKH device since 2007.

Median 510(k) review, days · EKH

Too few EKH 510(k)s in any year since 2007 to give a median.

Recalls per year · EKH

No recall names EKH since 2007.

Adverse event reports per year · EKH

5in 2023

2014: 22015: 12016: 12017: 42018: 22019: 12020: 12023: 5
2007high 5 (2023) · low 0 (2007)2025

MAUDE reports naming product code EKH, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—02
20150—01
20160—01
20170—04
20180—02
20190—01
20200—01
20210—00
20220—00
20230—05
20240—00
20250—00
20260—0—

More from Pacific Dental Corp.

22 FDA decisions under this applicant name. See the company

  • K821782Beach Anesthetic Syringe Cartr. TypePacific Dental Corp. · 1982
  • K821784Beach Gingival Retraction Instr. Type BPacific Dental Corp. · 1982
  • K821788Beach Deriosteal Elevator, #2 StraightPacific Dental Corp. · 1982
  • K821790Beach Excavator's NO. 1 & NO. 2Pacific Dental Corp. · 1982
  • K821777Beach Mouth MirrorPacific Dental Corp. · 1982

Recent decisions in EKH

The EKH category page

  • K823321Dental Instruments - CarverMiltex, Inc. · 1982
  • K780528Premier Carvers, Style #21C & 21DPremier Dental Products Co. · 1978

https://510kreport.com/device/K821785 · printed Nov 6, 2026

Cite this page

510(k) Report. “K821785: Beach Amalgam Carver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821785

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026