Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Brasseler USA with 4 510(k) clearances and 3 device recalls. The most recent is a device recall dated Jan 11, 2024: Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 11, 2024 | Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.Class II · The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the han | Device recalls |
| Dec 11, 2019 | Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used forClass II · 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann P | Device recalls |
| Oct 18, 2019 | BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill inClass II · One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. | Device recalls |
| Apr 3, 2003 | SMALL HIGH SPEED MOTOR DRILL SYSTEMK030172 · HBE | 510(k) clearances |
| Jan 14, 1999 | DENTAL STERLIZATION TRAY/CASSETTEK983223 · FRG | 510(k) clearances |
| Jan 5, 1996 | 2.0 X 6MM SCREWK955140 · DZL | 510(k) clearances |
| Mar 7, 1995 | KIRSCHNER (K-WIRE), STEINMAN PINSK945670 · JDW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
