FDA Registration
Active
🇮🇹 Italy
Kerr Italia, S.r.l.
Reg #: 8020994
·
FEI: 1000231788
·
Expires 2026
Products
24
Proprietary Names
325
Establishment Types
4
Classifications
24
Registration Details
- Registration Name
- Kerr Italia, S.r.l.
- Registration Number
- 8020994
- FEI Number
- 1000231788
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Passanti, 174
- City
- SCAFATI Salerno
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K162257
Owner / Operator
- Firm Name
- SYBRON DENTAL SPECIALTIES, INC.
- Operator Number
- 9029565
- Address
- 1889 W Mission Blvd, --
- City
- Pomona
- State
- CA
- Postal Code
- 91766
- Country
- US
- Correspondent
- Jennifer Evans
US Agent
- Business Name
- Sybron Dental Specialties
- Contact Name
- Jennifer Evans
- Address
- 1717 W Collins Ave
- City
- Orange
- State
- CA
- ZIP
- 92867
- Country
- US
- [email protected]
- Phone
- 714 5167795
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 1984-07-31 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2017-01-05 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2011-10-31 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 1996-10-02 |
| Bur, Dental | EJL | Class 1 | Dental | No | 1993-11-12 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2011-11-01 |
| Material, Impression | ELW | Class 2 | Dental | No | 2011-11-28 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2000-01-13 |
| Point, Abrasive | EHL | Class 1 | Dental | No | 1996-07-16 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2015-06-26 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2006-08-07 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2021-04-22 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2005-11-14 |
| Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | MZW | Class 2 | Dental | No | 2008-12-17 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2007-11-05 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2014-02-13 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 1996-10-02 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2001-01-09 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 1995-09-13 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2003-08-05 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 1977-12-15 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2005-08-10 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2016-05-16 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 1996-03-20 |
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
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
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
LVI Anterior Direct Ressin Preparation Logic Set
Hornbrool Prep Logic Set
Anterior Composite Logic Set
Laminate Veneer Logic Set
Axial Reduction Logic Set
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
Turbo Chamfer Preparation Logic Set
BruxZir Logic Set
Reverse Preparation Logic Set
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
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
Composite Surface Treatment
OptiDisc
Zone
ZoneFree
Take 1 Advanced Bite
Maxcem Elite Chroma
Extrude
SimpliShade Self-Adhesive Flow
Vertise Flow
Premise
OptiBond eXTRa Universal
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device