Kerr Italia, S.r.l.

FDA Device Registration & Listing · SCAFATI Salerno, IT · Registration 8020994

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8020994
FEI Number
1000231788
Entity Name
Kerr Italia, S.r.l.
City/State/Country
SCAFATI Salerno, IT
Establishment Address
Via Passanti, 174, SCAFATI Salerno 84018, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SYBRON DENTAL SPECIALTIES, INC. (Owner Number: 9029565)
Owner / Operator Contact Address
1889 W Mission Blvd, --, Pomona, CA 91766, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Life Harmonize Composite SimpliShade Composite Silane Silane Primer TF Adaptive Files Traverse Files TF (Twisted Files) ZenFlex Files Triple Flex Files K-Files LA Axxess Hedstrom Files Barbed Broach Pathfinder K-Flex Files Pathfinder CS K3XF Files Quantec Files ZenFlex One Sterile and Non-Sterile Files Traverse Orifice and Glide Path File Quantec Axxess Files Traverse Orifice Opener LightSpeed LSX K3 Files Root Canal Reamers LightSpeed CRX Traverse Glide Path File FibreKor Fiber Post Drill FibreKleer 4X Fiber Post Drill Kerr Carbides Post Drills Bur Block Hawe Jet Carbides Jet Carbides LA Axxess BluWhite Carbides Axis Carbide Burs LVI Aesthetic Inlay/Onlay Logic Set GrayGates IPR Logic Set R.A.P.T.O.R. Resin Sculpting Logic Set MW Series Finishing Logic Set Crown Removal Logic Set Comprehensive Universal Cutter Logic Set Posterior Composite Logic Set TDF Carbide Logic Set Vylon Resources Logic Set Carbide Burs Melker Root Shaping Logic Set NTI Soft Tissue Trimmer Tri-fissure All Ceramic Logic Set E$D Sample Logic Set All-Purpose Esthetic Logic Set TDF Series Personalized Logic Set Endodontic Access Logic Set Lowe Crown & Bridge Logic Set TDF Series Composite Logic Set Razor T&F Carbides Barbed Broaches SimpliShade BulkFill Flow SimpliShade BulkFill Breeze Self-Adhesive Resin Cement Breeze Point 4 Harmonize Super clear Revolution Formula 2 Dispensing Tips AlgiNot OptiBond Solo Plus Biosplint Adhesive Herculite XRV Cleanic Hawe Paste for Implants Luster Paste Prophy Paste Cleanpolish Superpolish Shammy Bright Polishing Paste Clinpro Perfect Pearl and Petite Pearl Prophy Contra Angles and Brushes PORCELAIN / CERAMICS NG Polishers & Prepolishers Pro-Brush GlossPlus Polisher Cup MINIDENTOFLEX Right Angle Mandrel COMPOSITE Glanzpolierer IDF Rec.Gloss Polishers Flame Pin Spannhalter Occlubrush Assorted Kit PINIDENTOFLEX GOLD/PRECIOUS ME PINIDENTOFLEX Pin-Holder MAXI SUPER ACRYLIC POLISHERs IDF Rec.Gloss Polishers Disc Occlubrush Cups & Points HiLuster Plus Polisher cup COMPOSITE Polishers & Prepolishers Opti1Step Polishers DIAMOND COMPOSITE Polishers COMPOSITE Vorpolierer IDF Rec.Gloss Polishers Mini HiLusterPlus Assortment OptiShine OptiClean IDF Rec.Gloss Polishers Cup MINIDENTOFLEX -COMPOSITE Polishers & Prepolishers Hawe Bristle Brushes IDF Rec.HiLuster Dia Polishers Hawe Polishing Assorted Kit GOLD/ AMALGAM / PRECIOUS METAL Polishers NTI Acrylic Polisher Ultimate FG IntraOral Logic Set CeraGlaze Porcelain Polishing Logic Set Prophy Brushes Zir-Cut Polisher Logic Set Cera-Glaze Ultimate Porcelain Logic Set NTI Green Abrasive Pro-Cup Latch Type Soft DiaGloss Polishing Logic Set Zir-Cut Zirconia Polisher Ortho Adhesive Removal Logic Set Acrylic Adjustment Logic Set NTI DiaGloss Polisher NTI PDQ Polisher AXIS Laminate Veneer Set NTI Brown Abrasive NTI Silicone Polisher CeraGlaze Intra-Oral Polishing Logic Set Valplast Logic Set UltraGloss Composite Polishing Logic Set Porcelain Adjusting & Polishing Logic Set Polisher Century Pack CeraGlaze Porcelain Lab Logic Set Personalized Logic Set Razor Sculpt and Polishing Logic Set Shammy Bright Discs NTI White Abrasive NTI Pink Abrasive PDQ Composite Polishing Brush Logic Set NTI Goldstar E4D Chairside Dental Designer Logic Set NTI CeraGlaze NTI PDQ2 Polisher ProGloss Ultimate Composite Polishing Logic Set Goldstar Gold Polishing Logic Set E4D Preparation Logic Set Pro-Cup Junior, Latch Type, Standard PDQ2 Composite Polishing Logic Set E4D Sdjust & Polish Logic Set Bite Adjustment Logic Set Interdental Wedges Clinical CAD/CAM Preparation Logic Set Pro-Cup Junior, Screw-Type, Standard Pro-Cup, Screw-Type, Soft NX3 Nexus Third Generation Nexus NX3 NX3 Flow-It ALC SonicFill 2 SonicFill 3 37% Phosphoric Acid Etching Gel OptiBond Gel Etchant Etching Gel Embonte Temp-Bond Original Take 1 Advanced Rigid Tray Permlastic Permlastic Adhesive Integra Take 1 Advanced Putty OptiBond FL Styptin Hemodettes GingiGEL Hemogin-L Take 1 Advanced TF Adaptive Paper Points K3/K3XF Paper Points ZenFlex ONE Paper Points TF Paper Points Autofit Paper Points PAPER POINTS Maxcem Elite Seal-Tight Chamfer Preparation Logic Set Veneer Preparation Logic Set Axial Reduction - MADC Raintree Essix Logic Set Zir-CUT Substructure Logic Set CEREC Starter Logic Set Belvedere C.C.V. Logic Set CEREC Prep N' Glaze Logic Set TDF Diamond Logic Set All Ceramic Logic Set LVI Anterior Direct Ressin Preparation Logic Set Hornbrool Prep Logic Set Anterior Composite Logic Set Laminate Veneer Logic Set Axial Reduction Logic Set TDF Series Composite Logic Set LA Axxess Nano Diamonds CEREC Prep & Finish Logic Set ZIR-CUT Diamond Bambino Diamonds KS Series Guide Pin Diamond Intensiv ProxoShape Diamond File Zir-Cut DDS Adjusting Logic Set Nano Prep Diamond Logic Set Personalized Logic Set Turbo Chamfer Preparation Logic Set BruxZir Logic Set Reverse Preparation Logic Set TDF Series Hornbrook Finish Logic Set Logic Set Axis Diamond Burs CEREC Intra-Oral Art & Passion Logic Set R.A.P.T.O.R. Diamond Modified Shoulder Logic Set Turbo Diamonds LAVA Preparation Logic Set Composite Logic Set LVI Esthetic Preparation Logic Set cerecdoctors.com Logic Set Radz & Soileau RSVP Logic Set BluWhite SimpliCut Pre-Sterile Diamond Burs SimpliShade Bleach White Herculite Ultra Herculite XRV Ultra OptiShade Bleach White OptiBond Universal OptiBond All-In-One elements IC PacMac Heat Plugger Buchanan Hand Plugger Condensor K3XF Gutta Percha Elements Gutta Percha Cartridge TF Adaptive Gutta Percha SoftCore TF Adaptive Obturator TF Adaptive Verifiers Gutta Percha Cartridge Zenflex Pre-Tip Gutta Percha Gutta Percha ZenFlex ONE Gutta Percha Autofit Backfill Gutta Percha SimpliCore Obturator Universal SimpliFill Apical Plugs SimpliCore Obturator for Zenflex One Autofit Gutta Percha K3 Gutta Percha Tip Snip- GP Gauge Wheel with Stand TF Gutta Percha Pre-contoured Metal Bands Cure-Thru Matrices Polishers Wedge Bags SuperCap Matrices, Steel, Cervical Premise Flowable Herculite XRV Ultra Flow Build-It FR Reamers Pulp Canal OptiBond Universal 360 TempBond Clear with Triclosan TempSpan Transparent Temporary Cement TempSpan Transparent Mixing Tips Automix Tips Bayonet Rings Intra-oral Tips Free-Flo Syringe, Tips Root Canal Tips Dynamic Mixing Tips Wastesaver Tips Static Mix Tips Dispensing Tips Temp-Bond NE Hawe Interdental Wedges Double Plugger Unidose Gun Adapt Luciwedge Dispensing Gun Transparent Cervical Foils & Matrices Luciwedge Blue Transparent Molar & Premolar Bands Composite Filling Spatula Composite Instruments SuperMat Single-Dose Dispensing Gun Blue Cervical Matrices Cure-Thru Cervical Foils TCF-Holder Hawe Tofflemire Matrices Hawe Steel Band Hawe Contoured Tofflemire Band Perforation Repair Cervical Foil & Posterior Blue View Grip Strips Extruder Hand Plugger SuperCap Matrices & Spools Blue Cervical Foils Explorer Curette MetaFix Prophy Clip Stop Strips Pulp Canal Sealer Pulp Canal Sealer EWT Sealapex Sealapex Xpress Tubli-Seal Xpress Tubli-Seal EWT Xpress Tubli-Seal EWT Tubli-Seal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 1984-07-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2017-01-05
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 1996-10-02
EJL Bur, Dental Dental Class 1 872.3240 1993-11-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-11-08
EMA Cement, Dental Dental Class 2 872.3275 2011-11-01
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-08-01
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2000-01-13
EHL Point, Abrasive Dental Class 1 872.6010 1996-07-16
EMA Cement, Dental Dental Class 2 872.3275 2011-10-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-11-01
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2015-06-26
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2015-06-26
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
EMB Zinc Oxide Eugenol Dental Class 1 872.3275 2006-08-07
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
ELW Material, Impression Dental Class 2 872.3660 2019-12-03
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
MVL Cord, Retraction Unknown Class U N/A 2021-04-22
ELW Material, Impression Dental Class 2 872.3660 2013-06-10
EKN Point, Paper, Endodontic Dental Class 1 872.3830 2005-11-14
EMA Cement, Dental Dental Class 2 872.3275 2008-12-17
MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief Dental Class 2 872.3275 2008-12-17
EIA Unit, Operative Dental Dental Class 1 872.6640 2007-11-05
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 2014-02-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 1996-10-02
EKM Gutta-Percha Dental Class 1 872.3850 2001-01-09
JEP Retainer, Matrix Dental Class 1 872.4565 1995-09-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-05
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-11-01
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 2003-08-05
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2023-01-14
EMA Cement, Dental Dental Class 2 872.3275 2011-10-31
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 1977-12-15
EMA Cement, Dental Dental Class 2 872.3275 2006-08-07
DZN Instruments, Dental Hand Dental Class 1 872.4565 2005-08-10
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2016-05-16
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2016-04-27
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2016-08-15

Official Correspondent

Jennifer Evans

US Agent Details

Jennifer Evans Business: Sybron Dental Specialties Email: jennifer.evans@envistaco.com Phone: (714) 5167795

Related Public Records

Same Entity

SYBRON DENTAL SPECIALTIES, 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
3027500898 EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada Escazu, San Rafael San Jose, CR
3003848022 Metrex Research LLC Madison, WI, US
1722021 METREX RESEARCH Romulus, MI, US
3031606517 Envista (Sichuan) Medical Device Co., Ltd. Ziyang Sichuan, CN
3028340833 EH Labs CZ s.r.o. Dvur Kralove nad Labem Hradec Kralove, CZ

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K941532 Bio-Probe, Inc. BIOCALEX 6/9 1994-08-02
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
K153476 Kuraray Noritake Dental, Inc. KATANA AVENCIA Block 2016-08-23

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.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020994. Last updated year: 2026. Please use registration number 8020994 when referencing this establishment in official correspondence.
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