Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021851820

FEI Number

3021851820

Entity Name

OSSEOTOUCH LLC

City/State/Country

Fairhope, AL, US

Establishment Address

20585 County Road 13/B, Fairhope, AL 36532, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

OSSEOTOUCH LLC (Owner Number: 10084531)

Owner / Operator Contact Address

20585 County Road 13/B, Fairhope, AL 36532, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BLEXO-LONGRT-PATHFINDERS BLEXO-ARCH-PATHFINDERS OSTEOTOM MM F 200D SINGLE PACK EXPANDER CURVED MM F EXP1C SINGLE PACK OSTEOTOM CURVED MM F 230C SINGLE PACK EXTRACTOR MM F EXTR1D SINGLE PACK INSERTER MM F INSD SINGLE PACK INSERTER HEXAGONAL CURVED MM F INSSW SINGLE PACK EXTRACTOR MMF EXTR4D SINGLE PACK OSTEOTOME AZ300 CURVED 20 SINGLE PACK OSTEOTOM CURVED MM F 200C SINGLE PACK EXPANDER CURVED MM F EXP2C SINGLE PACK INSERTER CURVED MM F INSC SINGLE PACK GENOA 2 SINGLE PACK EXPANDER MM F EXP2D SINGLE PACK OSTEOTOME AZ100P CURVED SINGLE PACK OSTEOTOME TRAY EXPANDER CURVED MM F EXP3AC SINGLE PACK OSTEOTOME BLACK RUBY R4 CURVED SINGLE PACK GENOA 3 SINGLE PACK OSTEOTOM MM F 100PD SHARPED SINGLE PACK OSTEOTOME AZ200 CURVED 20 SINGLE PACK PLUS HANDPIECE KIT WITH INSTRUMENTS KIT OSTEOTOMES CURVED STO EXTRACTOR CURVED MM F EXTR4C SINGLE PACK STANDARD OSTEOTOME HANDPIECE GENOA 2 CURVED SINGLE PACK OSTEOTOME AZ230 CURVED SINGLE PACK OSTEOTOM CURVED MM F 100PC SHARPED SINGLE Pack OSTEOTOM CURVED MM F 360C SINGLE PACK BLADE MMFCUT SINGLE PACK OSTEOTOME AZ200 STRAIGHT SINGLE PACK 2308 HOOK EXTRACTOR MM F EXTR3D SINGLE PACK OSTEOTOME BLACK RUBY R2 STRAIGHT SINGLE PACK OSTEOTOM MM F 160D SINGLE PACK CROWN REMOVER HOOKS KIT KIT OSTEOTOMES SPECIAL STRAIGHT SWEDEN & MARTINA OSTEOTOME BLACK RUBY R1 STRAIGHT SINGLE PACK OSTEOTOME AZ200 CURVED SINGLE PACK OSTEOTOME BLACK RUBY R3 CURVED SINGLE PACK MAGNETIC MALLET FOOTSWITCH COMPLETE SWANN & MORTON SM64 CODICE 05904 - BALDES OSTEOTOME AZ160 CURVED SINGLE PACK EXPANDER MM F EXP1D SINGLE PACK GENOA 3 CURVED SINGLE PACK EXTRACTOR MM F EXTR5D SINGLE PACK OSTEOTOME BLACK RUBY R3 STRAIGHT SINGLE PACK OSTEOTOME AZ300 STRAIGHT SINGLE PACK OSTEOTOME AZ230 STRAIGHT SINGLE PACK OSTEOTOME AZ100 STRAIGHT SINGLE PACK EXPANDER MM F EXP3AD SINGLE PACK OSTEOTOM MM F 300D SINGLE PACK .. EXTRACTOR CURVED MM F EXTR3C SINGLE PACK GENOA 1 SINGLE PACK 2306 HOOK EXTRACTOR CURVED MM F EXTR2C SINGLE PACK CROWN REMOVER HANDPIECE EXTRACTOR CURVED MM F EXTR5C SINLGE PACK SPLIT CURVED COAST SINGLE PACK OSTEOTOM CURVED MM F 330C SINGLE PACK OSTEOTOME AZ300 CURVED SINGLE PACK OSTEOTOME AZ160 STRAIGHT SINGLE PACK OSTEOTOME AZ100P STRAIGHT SINGLE PACK OSTEOTOM MM F 330D SINGLE PACK OSTEOTOM CURVED MM F 300C SINGLE PACK CROWN REMOVER KIT HOOKS TRAY OSTEOTOME AZ230 CURVED 20 SINGLE PACK BLADES PLASTIC HOLDER UB 31X82X11 TRANSP. PP 23 GENOA 1 CURVED SINGLE PACK EXTRACTOR CURVED MM F EXTR1C SINGLE PACK OSTEOTOME AZ160 CURVED 20 SINGLE PACK 2307 HOOK OSTEOTOME BLACK RUBY R4 STRAIGHT SINGLE PACK EXTRACTOR MM F E XTR2D SINGLE PACK- OSTEOTOME AZ100 CURVED 20 SINGLE PACK OSTEOTOME AZ100 CURVED SINGLE PACK SPLIT STRAIGHT SINGLE PACK OSTEOTOM CURVED MM F 100C SINGLE PACK PLUS OSTEOTOME HANDPIECE OSTEOTOME AZ100P CURVED 20 SINGLE PACK OSTEOTOME BLACK RUBY R1 CURVED SINGLE PACK OSTEOTOM MM F 230D SINGLE PACK KIT OSTEOTOMES STRAIGHT STO OSTEOTOME BLACK RUBY R2 CURVED SINGLE PACK BLADE CURVED MM F CUTC SINGLE PACK OSTEOTOME BLACK RUBY R5 STRAIGHT SINGLE PACK OSTEOTOM CURVED MM F 160C SINGLE PACK OSTEOTOM MM F 360D SINGLE PACK KIT OSTEOTOMES SPECIAL CURVED SWEDEN & MARTINA SPLIT CURVED SINGLE PACK OSTEOTOME BLACK RUBY R5 CURVED SINGLE PACK BLEXOO-LEFTSIDE-ANGLEFIT BLEXO-MICRO-PATHFINDERS BLEXO-RIGHTSIDE-ANGLEFIT BLEXO-DISTAL-ANGLEFIT BLEXO-MESIAL-ANGLEFIT BLEXO-SLIM-PATHFINDERS EXTRACTOR3 - REVERSE Easyroot Magnetic Mallet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2022-03-03
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2022-03-03

Official Correspondent

Claudio De Giglio

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSSEOTOUCH LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K894785	Fdt Precision Machine Co., Inc.	SURGICAL CHISEL/OSTEOTOME	1989-08-18
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01

Similar Registrations

Registration Number	Establishment Name	Location
3003644849	DR. FRIGZ INTERNATIONAL (PVT) LTD.	SIALKOT, Punjab, PK
3007648354	FETZER MEDICAL GMBH & CO.KG	Tuttlingen Baden-Wurttemberg, DE
8010257	HERMANN MEDIZINTECHNIK GMBH	FRIDINGEN Baden-Wurttemberg, DE
1038671	EXACTECH, INC.	GAINESVILLE, FL, US
3011922183	META ERGONOMICA S.R.L.	Turbigo Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021851820. Last updated year: 2026. Please use registration number 3021851820 when referencing this establishment in official correspondence.