Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710113

FEI Number

3003348399

Entity Name

ORTHODONTIC MANUFACTURER SIA SRL

City/State/Country

ROCCA D EVANDRO Caserta, IT

Establishment Address

ZONA INDUSTRIALE, VIA VANDRA, ROCCA D EVANDRO Caserta 81040, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ORTHODONTIC MANUFACTURER SIA SRL (Owner Number: 9080887)

Owner / Operator Contact Address

ZONA INDUSTRIALE, --, ROCCA D'EVANDRO (CE), IT-CE 81040, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SIA ORTHODONTIC MANUFACTURER SIA ORTHODONTIC MANUFACTURER JET JET LP ZIP T7 ZIP T6 SIA ORTHODONTIC MANUFACTURER SUPERTECH MICROFIT BT2 - BITURBO ZIP TS2 - ZIP LP SIA ORTHODONTIC MANUFACTURER HEXAGON SLIDING AND CRIMPABLE HOOKS CRIMPABLE STOP SIA ORTHODONTIC MANUFACTURER FACEBOW SIA ORTHODONTIC MANUFACTURER INTERPROXIMAL INCREMENTAL GAUGE SIA ORTHODONTIC MANUFACTURER IPR SIA ORTHODONTIC MANUFACTURER SIA ORTHODONTIC MANUFACTURER MACH3 SIA ORTHODONTIC MANUFACTURER I-ARCH SIA ORTHODONTIC MANUFACTURER SIA ORTHODONTIC MANUFACTURER ACTIVA D-bar

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2012-01-13
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2001-03-19
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2018-01-12
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2001-03-19
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2001-03-19
KCR	Facebow	Dental	Class 1	872.3220	2014-06-10
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2016-10-24
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2012-01-13
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2012-01-13
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2012-01-13
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2001-03-19
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2012-01-13

Official Correspondent

No official correspondent registered.

US Agent Details

Katie Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

ORTHODONTIC MANUFACTURER SIA SRL

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710113. Last updated year: 2026. Please use registration number 9710113 when referencing this establishment in official correspondence.