Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003231822

FEI Number

3003231822

Entity Name

BIOLOREN SRL

City/State/Country

SARONNO Varese, IT

Establishment Address

VIA ALESSANDRO VOLTA 59, SARONNO Varese IT-21047, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOLOREN SRL (Owner Number: 9059794)

Owner / Operator Contact Address

VIA ALESSANDRO VOLTA 59, --, SARONNO, IT-VA 21047, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112186

PMA Number

N/A

All Registered Proprietary Names

INFIBRA post FIBER DISK AND BLOCK PERMANENT, TRILOR InFibra scissor Fiber Disks and Blocks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2006-07-05
ELR	Post, Root Canal	Dental	Class 1	872.3810	2003-11-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-03-19
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2018-06-28
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-11-14

Official Correspondent

ANDREA RATTI

US Agent Details

Silvia Tamarri Business: Thema Corp Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

BIOLOREN 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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003231822. Last updated year: 2026. Please use registration number 3003231822 when referencing this establishment in official correspondence.