SpofaDental a.s.

FDA Device Registration & Listing · Jicin Hradec Kralove, CZ · Registration 3007743883

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
3007743883
FEI Number
3007743883
Entity Name
SpofaDental a.s.
City/State/Country
Jicin Hradec Kralove, CZ
Establishment Address
Markova 238, Jicin Hradec Kralove 506 01, CZ
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
K123595
PMA Number
N/A

All Registered Proprietary Names

SoftClamp Take 1 Advanced Rigid Tray Take 1 Advanced GingiKNIT+ Nonimpregnated Retraction Cord GingiBRAID+ Nonimpregnated Retraction Cord GingiBRAID+ ShortCut Nonimpregnated Retraction Cord UniBRAID+ Nonimpregnated Retraction Cord KromaFaze Identic Integra Image Alignate Styptin Hemodettes GingiGEL Hemogin-L OptiView OptiView Premier Integra Take 1 Advanced Putty 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 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 Composite Surface Treatment OptiDisc Hawe Testset X-Ray Kwik-Bite Digital Imaging & Accessories Super-Bite Super-Bite Senso Endo-Bite Senso Hawe Imaging Plate Holder Test Bite Wafer Disclosing Wax Occlusal Indicator Wax Take 1 Advanced Bite Impression Compound AlgiNot 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 VPS Adhesive Nexus RMGI Breeze RMGI

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EEF Clamp, Rubber Dam Dental Class 1 872.6300 2006-03-10
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
ELW Material, Impression Dental Class 2 872.3660 2013-06-10
MVL Cord, Retraction Unknown Class U N/A 2018-01-09
ELW Material, Impression Dental Class 2 872.3660 2016-07-06
MVL Cord, Retraction Unknown Class U N/A 2021-04-22
EIG Retractor, All Types Dental Class 1 872.4565 2005-04-29
ELW Material, Impression Dental Class 2 872.3660 2019-12-03
ELW Material, Impression Dental Class 2 872.3660 2018-01-09
MVL Cord, Retraction Unknown Class U N/A 2018-01-09
EHL Point, Abrasive Dental Class 1 872.6010 1996-07-16
EHJ Disk, Abrasive Dental Class 1 872.6010 1996-03-20
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 1996-03-19
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 1977-12-15
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
ELW Material, Impression Dental Class 2 872.3660 2011-12-06
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
DZN Instruments, Dental Hand Dental Class 1 872.4565 2005-08-10
ELW Material, Impression Dental Class 2 872.3660 2019-11-25
EMA Cement, Dental Dental Class 2 872.3275 2013-02-21

Official Correspondent

Jennifer Evans

US Agent Details

Jennifer Evans Business: Sybron Dental Specialities Inc. 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
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007743883. Last updated year: 2026. Please use registration number 3007743883 when referencing this establishment in official correspondence.
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