Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021050

FEI Number

3002936446

Entity Name

ASA DENTAL S.P.A.

City/State/Country

MARLIA Lucca, IT

Establishment Address

VIA DELLE PIAGGIE, 1A, MARLIA Lucca 55014, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ASA DENTAL S.P.A. (Owner Number: 8021050)

Owner / Operator Contact Address

VIA VALENZANA, 60, --, BOZZANO, IT-NOTA 55054, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DAPPEN DISHES PROBE Mouth Mirror SCAN SYRINGE Rubber Dam Clamp Disposable Earloop Mask Dental Needle Holder Facebow Dental Instrument Tray SALIVA EJECTOR DISPOSABLE Dental Hand Instruments Patient bibs; polytowels Impression Trays

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2005-10-06
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2002-01-07
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2001-11-09
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2005-10-06
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2010-06-28
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-04
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2008-01-15
KCR	Facebow	Dental	Class 1	872.3220	2012-11-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-01-15
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	1994-02-16
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2008-01-15
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2008-05-14
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1986-08-18

Official Correspondent

Alessandro Malfatti

US Agent Details

MARCELLO GIORDA Business: Asa Dental USA Corp. Email: Marcello.giorda@asadental.com Phone: (631) 5744435

Related Public Records

Same Entity

ASA DENTAL S.P.A.

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

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1525838	ABRASIVE TECHNOLOGY, LLC	LEWIS CENTER, OH, US
3012312751	DENTAL BRANDS FOR LESS	Markham Ontario, CA
3006847937	Premium Plus International Limited	Hong Kong, HK
3004130302	MICERIUM S.P.A.	AVEGNO Genova, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021050. Last updated year: 2026. Please use registration number 8021050 when referencing this establishment in official correspondence.