510(k) Report

510(k) · Cleared

Cleared

Reprocessed Diamond Burs

K041978510(k) TraditionalCleared Nov 23, 2004123-day reviewClass II21 CFR 882.4310

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

Alliance Medical Corp. · NLN Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

Cleared on Nov 23, 2004 as substantially equivalent to K901967 (Micro-Aire Surgical Instruments, Inc., 1990) after a 123-day review. Its family tree reaches back 1 generation to 1990.

Decided
Nov 23, 2004
Review
123 days
Class
Class II
Product code
NLN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K901967 (1990). No later device cites it as a predicate yet.

K901967 · Dendia Werk Burs and Cutting Discs · Micro-Aire Surgical Instruments, Inc. · 19901990199520002005
K901967 · Dendia Werk Burs and Cutting Discs · Micro-Aire Surgical Instruments, Inc. · 19900
  1. Root · 1 generation backK901967 Dendia Werk Burs and Cutting DiscsMicro-Aire Surgical Instruments, Inc. · 1990
  2. This deviceK041978 Reprocessed Diamond BursAlliance Medical Corp. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901967Dendia Werk Burs and Cutting DiscsMicro-Aire Surgical Instruments, Inc.1990—
0 (this device)K041978Reprocessed Diamond BursAlliance Medical Corp.2004—
FIG. 1 — Lineage of K041978, 1990–2004Source: 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 NLN? 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? (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
*K901967Dendia Werk Burs and Cutting Discs
Summary page 1
…Diamond Instrument, ENT diamond Coated bur Predicate device: K# Device Description Product Code K901967 DendiaWerk Burs and Cutting DZP Discs Device description: Diamond Burs…
Micro-Aire Surgical Instruments, Inc.1990—

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 NLN devices

NLN Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NLN

FDA has decided no NLN device since 2007.

Median 510(k) review, days · NLN

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

Recalls per year · NLN

No recall names NLN since 2007.

Adverse event reports per year · NLN

3in 2023

2015: 12023: 3
2007high 3 (2023) · low 0 (2007)2025

MAUDE reports naming product code NLN, 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—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—03
20240—00
20250—00
20260—0—

What is it indicated for?

Reprocessed Diamond Burs are indicated for use in patients requiring surgery involving bone and bony structures.

Indications for use as stated in the FDA summary.

More from Alliance Medical Corp.

36 FDA decisions under this applicant name. See the company

  • K060648Reprocessed Phacoemulsification TipsAlliance Medical Corp. · 2007
  • K061045Reprocessed Electrophysiology CathetersAlliance Medical Corp. · 2006
  • K060049Reprocessed Compression SleevesAlliance Medical Corp. · 2006
  • K060091Alliance Medical Corporation Reprocessed Compression SleevesAlliance Medical Corp. · 2006
  • K053316Reprocessed Compression SleevesAlliance Medical Corp. · 2006

https://510kreport.com/device/K041978 · printed Nov 3, 2026

Cite this page

510(k) Report. “K041978: Reprocessed Diamond Burs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K041978

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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