Brasseler USA I, L.P.

Savannah, GA, US

Brasseler USA I, L.P. appears in FDA device records in Savannah, GA. FDA records list 4 510(k) clearances between 1995-03-07 and 2003-04-03, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 4 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 4
Registered establishments: 2

FDA records under these names

2 names

FDA records resolved to Brasseler USA I, L.P. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

BRASSELER U.S.A. DENTAL, LLCregistration
Brasseler U.S.A. Medical, LLCregistration, enforcement report, recall

510(k) clearance history

FDA records hold 4 510(k) clearances for Brasseler USA I, L.P. between 1995 and 2003. The busiest year on record is 1995, with 1. The most recent is 2003, with 1.

Clearances by year, as a table

510(k) clearance decisions for Brasseler USA I, L.P., by decision year
Year	Clearances
1995	1
1996	1
1999	1
2003	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K030172	SMALL HIGH SPEED MOTOR DRILL SYSTEM	HBE	Substantially Equivalent	2003-04-03
K983223	DENTAL STERLIZATION TRAY/CASSETTE	FRG	Substantially Equivalent	1999-01-14
K955140	2.0 X 6MM SCREW	DZL	Substantially Equivalent	1996-01-05
K945670	KIRSCHNER (K-WIRE), STEINMAN PINS	JDW	Substantially Equivalent	1995-03-07

Registered establishments

FDA registered establishments for Brasseler USA I, L.P., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1032227	1032227	BRASSELER U.S.A. DENTAL, LLC	1 Brasseler Blvd, SAVANNAH, GA 31419 US	2026	DZA DZM DZN DZP EAT EAX EBF EBL EBW EBZ and 68 more, listed in full below
2025102	3004949275	Brasseler U.S.A. Medical, LLC	1 Brasseler Blvd, Savannah, GA 31419 US	2026	DWH FQH FRG GFA GFF HAB HBE HSZ HTT HTY and 6 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1008-2024	Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.	The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.	Class II	2024-01-11	Open, Classified
Z-0707-2022	Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S	One lot of product was distributed in unsealed packaging	Class II	2022-01-28	Terminated
Z-0884-2020	Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.	103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.	Class II	2019-12-11	Terminated
Z-0591-2020	BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.	One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.	Class II	2019-10-18	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain