Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031054

FEI Number

1000558210

Entity Name

POLYDENTIA S.A.

City/State/Country

MEZZOVICO-Vira Ticino, CH

Establishment Address

VIA CANTONALE 47, MEZZOVICO-Vira Ticino 6805, CH

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Polydentia S.A. (Owner Number: 9076845)

Owner / Operator Contact Address

Via Cantonale 47, Mezzovico- Vira, CH-TI CH-6805, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hemo-Wedge Macro-Wedges HY-DROP Hy-Drop Forte Vista-Tec Ultralight Matrices Diamond 24 myQuickmat Classico starter kit Stop-Card Unica anterior matrices LumiContrast myTines Small Refill Maximat Plus Wedges myTines Large Refill ID-Rings clip&Splint myTines Medium Refill Endo-Stops myQuickmatrix forceps Junior Quickmat sectional matrices myQuickmat All-round introkit Junior LumiContrast Sectional Matrices myTines Refill Quickring Forceps Interdental Wood Wedges Unica minideep anterior myTines Junior Refill myQuickmat Forte starter kit API autoclavable placement instrument Maxi ID-Rings myJunior Kit QuickmatFLEX Unica anterior introkit Quickmat Deluxe Kit Cotton Roll Holder myRing Junior QuickmatFIT myForceps Quickmat All-round Quickmat Prime 3wedge myClip 2 Unica Proximal myQuickmat classico kit myQuickmat Prime kit The Wedge myWedge myRing classico myClip Junior myTines GO myTines Prime Unica Proximal Deep myRing Prime Unica master kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2013-02-21
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	1998-09-23
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	1996-06-17
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	1996-06-17

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Polydentia S.A.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031054. Last updated year: 2026. Please use registration number 8031054 when referencing this establishment in official correspondence.