Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031010

FEI Number

1000185904

Entity Name

MAILLEFER INSTRUMENTS HOLDING SARL

City/State/Country

BALLAIGUES Vaud, CH

Establishment Address

CH. DU VERGER 3, BALLAIGUES Vaud CH-1338, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DENTSPLY SIRONA INC (Owner Number: 2511302)

Owner / Operator Contact Address

221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drill single patient use tack drills EMERGENCE PROFILE Bracket Height Gauge Drills GATES LARGO MONO Surgery Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	1977-12-15
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	1998-09-08
EJL	Bur, Dental	Dental	Class 1	872.3240	1997-06-27
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	Class 2	878.3680	2024-05-28
JEY	Plate, Bone	Dental	Class 2	872.4760	2013-01-04
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2026-06-11
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	1989-01-27
ELR	Post, Root Canal	Dental	Class 1	872.3810	1984-11-16
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	1977-12-15
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2006-10-26
LQY	Locator, Root Apex	Unknown	Class U	N/A	2015-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-04
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2013-01-04
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-04
EZX	Mesh, Surgical, Metal	General, Plastic Surgery	Class 2	878.3300	2013-01-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-04
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	1997-02-05
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-04
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	1996-08-21
LRN	Wire, Surgical	Orthopedic	Class 2	888.3030	2013-01-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-04
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-01-04
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2023-12-14
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	1984-11-16
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	1995-03-27
EKM	Gutta-Percha	Dental	Class 1	872.3850	1992-08-24
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2026-06-12
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2024-05-28
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2026-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA INC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9612618	DEGUDENT GMBH	Rosbach V.D.H. Hesse, DE
3003756493	DENTSPLY INDUSTRIA E COMERCIO LTDA	PIRASSUNUNGA Sao Paulo, BR
3001226627	RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)	ST. EGREVE Isere, FR
3003136642	OraMetrix GmbH	Berlin Brandenburg, DE
3000303964	DENTSPLY DENTAL (TIANJIN) CO., LTD.	TEDA Tianjin, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031010. Last updated year: 2026. Please use registration number 8031010 when referencing this establishment in official correspondence.