Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680845

FEI Number

3000368601

Entity Name

SDS de Mexico S. de R.L. de C.V.

City/State/Country

MEXICALI, B.C. C.P. Baja California, MX

Establishment Address

CIRCUITO SUR NUM. 31, PARQUE IND. NELSON, MEXICALI, B.C. C.P. Baja California 21395, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SYBRON DENTAL SPECIALTIES, INC. (Owner Number: 9029565)

Owner / Operator Contact Address

1889 W Mission Blvd, --, Pomona, CA 91766, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Dispensing Tips 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 Silane Silane Primer 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-11-05
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	1977-12-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-11-01
ELW	Material, Impression	Dental	Class 2	872.3660	2011-11-01
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-01-14
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2007-11-05
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-08-05
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-10-31
EAT	Tester, Pulp	Dental	Class 2	872.1720	2011-09-13
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2011-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-10-31
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
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2007-11-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EAY	Light, Fiber Optic, Dental	Dental	Class 1	872.4620	1992-08-12
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2006-08-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2018-11-14
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-11-01
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-11-01
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2003-12-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-07-24
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-11-01
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-10-31
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2002-07-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EAT	Tester, Pulp	Dental	Class 2	872.1720	2011-09-14
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2023-09-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-05
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2012-08-09
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2012-08-09
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2012-08-09
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2007-11-05
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2010-11-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-11-01
EAT	Tester, Pulp	Dental	Class 2	872.1720	2007-11-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-03-17
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2005-07-29
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2010-11-29
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2026-01-09
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2003-12-22
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-11-01
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	1982-12-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-11-01
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2019-11-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-11-01
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	1978-02-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-11-08
DZM	Needle, Dental	Dental	Class 1	872.4730	2014-12-29
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-02-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2007-06-27
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2017-09-21
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2017-09-21
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2002-07-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-11-01
ELW	Material, Impression	Dental	Class 2	872.3660	2018-01-09
MVL	Cord, Retraction	Unknown	Class U	N/A	2018-01-09
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2018-02-21
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-11-05
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-10-31
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2011-12-06
EMA	Cement, Dental	Dental	Class 2	872.3275	2015-08-18
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2011-09-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-11-01
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-07-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-11-21
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-10-31
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2011-09-14
EAX	Mirror, Mouth	Dental	Class 1	872.4565	1996-10-02
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2014-12-29
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-05
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1977-12-15
ELW	Material, Impression	Dental	Class 2	872.3660	2010-01-04
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
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
EKM	Gutta-Percha	Dental	Class 1	872.3850	2001-01-09
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2014-12-29
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-11-01
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
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2011-09-14
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

Procoro Herrera Business: Sybron Dental Specialties, Inc. Email: SybronDentalSpecialtiesRA@envistaco.com Phone: (657) 3416074

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
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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13

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.
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680845. Last updated year: 2026. Please use registration number 9680845 when referencing this establishment in official correspondence.