FDA Registration
Active
🇲🇽 Mexico
SDS de Mexico S. de R.L. de C.V.
Reg #: 9680845
·
FEI: 3000368601
·
Expires 2026
Products
47
Proprietary Names
217
Establishment Types
1
Classifications
47
Registration Details
- Registration Name
- SDS de Mexico S. de R.L. de C.V.
- Registration Number
- 9680845
- FEI Number
- 3000368601
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CIRCUITO SUR NUM. 31, PARQUE IND. NELSON
- City
- MEXICALI, B.C. C.P. Baja California
- Country
- MX
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
US Agent
- Business Name
- Sybron Dental Specialties, Inc.
- Contact Name
- Procoro Herrera
- Address
- 200 S. Kraemer Blvd.
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 657 3416074
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2007-11-05 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 1977-12-15 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2011-11-01 |
| Material, Impression | ELW | Class 2 | Dental | No | 2011-11-01 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2023-01-14 |
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2007-11-05 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2003-08-05 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2011-10-31 |
| Tester, Pulp | EAT | Class 2 | Dental | No | 2011-09-13 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2007-11-05 |
| Light, Fiber Optic, Dental | EAY | Class 1 | Dental | No | 1992-08-12 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2006-08-07 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2011-11-01 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2003-12-22 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2002-07-02 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2023-09-26 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2012-08-09 |
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2012-08-09 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2012-08-09 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2007-11-05 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2005-07-29 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2026-01-09 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2003-12-22 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 1982-12-15 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2019-11-25 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 1978-02-15 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2014-12-29 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2007-06-27 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2018-01-09 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2025-07-02 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 1996-10-02 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2014-12-29 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2007-11-05 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 1977-12-15 |
| Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | MZW | Class 2 | Dental | No | 2008-12-17 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2001-01-09 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2014-12-29 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2007-04-12 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 1982-12-15 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2021-04-20 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2003-08-05 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2008-12-01 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2017-05-04 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 1982-12-15 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 1982-12-15 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 1982-12-15 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2023-11-17 |
Proprietary Names
GUARDIAN SEAL
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
Build-It FR
Correct VPS Putty
OptiBond Universal 360
Fill-In
Vitality Scanner
Apex Locator
Vitality Scanner Tip
SimpliShade Self-Adhesive Flow
Vertise Flow
Modeling Resin
Point 4 Transparent
37% Phosphoric Acid Etching Gel
OptiBond Gel Etchant
Etching Gel
NX3 Try-In Gels
Light Guides for Curing Lights
Embonte
Temp-Bond Original
OptiBond eXTRa Universal
Construct
CoreRestore2
Cement-It
SonicFill Handpiece, MULTIFlex Coupling, Lubrication Spray
Flow-It ALC
Silane
Silane Primer
Premise
Revolution Formula 2
Touch N Heat
Spoon Tip
Touch N Heat Carrier
Hot Pulp Test Tip
Touch N Heat Plugger
Ormco Digital Bonding
Premise Flowable
Herculite XRV Ultra Flow
SmearClear
Optibond XTR
Premise Indirect Primary Dentin
Bond-1 Primer & Adhesive
Elements Diagnostic Unit
Alert
Alert Condensable Composite
Adaptor
Jackson Expander
Hex Appliance (Hilgers)
Bluegrass Tongue Trainer
Activators
Spring Loaded Space Regainer
Frankel
W Arch Expander
Distal Jet Molar Uprighter
Dischinger Lower Expansion Appliance
Lower Bi-Helix
Kiddie Partial
DeLuke Bonded Framless Expander
MAH Freedom Appliances
Orthopedic Corrector
ACCO Expander
Shamey Expander
Distal Jet
Fan Expider Expander
Goshgarian Transpalatal Arch
Nance Button
Vertical Crib
Hilgers Pendex
MCLR
Hilgers Pendulum
Transpalatal Arch
Lingual Arch
Mayes Penguin
Bionator
Nord Expander
Schwarz Appliances
Band and Loop Space Maintainer
Sagittal Appliances
Hayrake -- Palatal with Spurs
Proactive (Spring Retainer)
EZ Bond Retainer
PhD Appliance
Tracey/Hilgers MDA Appliance
Cetlin Lip Bumper
Palatal Thumb Crib
Hawley Retainer
Spring Retainer
Wilson 3-D Appliance
Twin Block
Orthodontic Appliance and Parts
Haas Expander
Lower Expander
Upper or Lower Removable Quad
Acrylic Bonded RPE
Rachet Expander
Arnold Expander
Rapid Palatal Expander
Spring Jet Expanders
Porter Arch
ZenSeal Pro Bio Ceramic Root Canal Sealer
NX3 Nexus Third Generation
Nexus NX3
NX3
Point 4
TempSpan Dual-Cure Temporary Crown & Bridge Material
TempSpan C&B
Demi Ultra
Mojo Try-In Gels
Mojo
SimpliShade BulkFill Flow
SimpliShade BulkFill
MIxing Tips
Nexus RMGI
Breeze RMGI
Opaque Dual Cure Resin
Elements Obturation Unit
Elements Obturation Cartridge
Fusio
GingiBRAID+ ShortCut Aluminum Potassium Sulfate Retraction Cord
GingiBRAID+ Aluminum Potassium Sulfate Retraction Cord
UniBRAID+ Aluminum Potassium Sulfate Retraction Cord
GingiKNIT+ Aluminum Potassium Sulfate Retraction Cord
Temphase
OptiBond FL
Demi Plus, Light Guides
Maxcem Elite Chroma
Artiste Nano Composite
Simile Composite
NeoFil
Premise Indirect Incisal
Nexus Universal
Nexus Universal Chroma
TempBond Clear with Triclosan
TempSpan Transparent Temporary Cement
TempSpan Transparent
Endoragard
Seal-Tight
Water Cooled Impression Tray
Originate Impression Trays
Putty Spacer
Three-In-One Impression Trays
Clear Impression Trays
Take 1 Hydro Bite
Correct Plus
Correct Quick
Correct V.P.S.
Optiguard
Maxcem Elite
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
PeelVue+
Breeze Self-Adhesive Resin Cement
Breeze
OptiBond Solo Plus
Biosplint Adhesive
SimpliShade Bleach White
Herculite Ultra
Herculite XRV Ultra
OptiShade Bleach White
Bond-It Enamel/Dentin Bonding System
Bond-It Primer
CLAMP
WIRE ORTHODONTIC
Spark Clear Aligner System
System B
Buchanan System B Plugger
Build-It Light Cure Material
EndoRing
SimpliCore Universal Verifier
SimpliCore Verifier for Zenflex One
Disposable Applicators
Brushes
Steri-Cassette
Steri-Cage
Red, White, & Blue Retainer
SIMPLI5
Bond-1 Dual Cure Activator
OptiBond Universal
OptiBond All-In-One
Kolor+ Plus
Bond-It Dual-Cure Activator
Harmonize Composite
SimpliShade Composite
Bond 1 SF
Bond-1 SF Solvent-Free SE Adhesive
Take 1 Retraction Paste
Premise Indirect Facial Dentin
Cervical
Herculite XRV
Construct Resin
SonicFill 2
SonicFill 3
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)