Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008808095

FEI Number

3008808095

Entity Name

CERAROOT S.L.

City/State/Country

Les Franqueses del Valles Barcelona, ES

Establishment Address

Parpers 13, Les Franqueses del Valles Barcelona 08520, ES

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

CERAROOT S.L. (Owner Number: 10034855)

Owner / Operator Contact Address

Parpers 13, Les Franqueses del Valles, ES-B 08520, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CeraRoot ceramic implant CeraRoot CeraRoot surgical kit CeraRoot zirconium oxide dental implant Transporter 16 long -steel (00516) Fixation Pin drill 1.5 Guided (FIP-150G) Sleeve for fixation pin drill 1.5 (BPL-1) Steel tweezers with ceramic tip (005.500) Sleeve for cylindrical drill 4.25 (BDC-CR) Cylindrical drill 2,00x14 guided (FAB-1687/04) Initial drill long guided (FAB-1706/02) Countersink 11- ceramic (00411) Cylindrical drill 4,20x18 guided (FAB-1688/04) Lab Analogue 16TL (008.162) Cylindrical drill 4,20x10 guided (FAB-1687/17) Twist drill 2.3 mm -ceramic (00202) Cylindrical drill 3,50x16 guided (FAB-1687/15) Impactor for implant 14 -steel/peek (005.214) bur extension -steel (00106) Transporter 16 short -ceramic (00617) Lab Analogue 21 (008.121) CeraRoot Guided Surgery System (02002S) Transporter TL - steel (005.342) Countersink 14- steel (00314) Transporter 11 -steel (00511) Countersink 12 - steel (FAB-1878) Cylindrical drill 2,00x10 guided (FAB-1687/02) Transporter 16 long -steel (00516-S) Bur extension -steel (AIP-3) Lab Analogue 14 (008.114) Twist drill 4.2 mm -ceramic (00205) Countersink 42 - steel (FAB-1877) Cylindrical drill 2,00x8 guided (FAB-1687/01) Transporter 34 -ceramic (00634) Countersink 11 - steel (FAB-1696) Cylindrical drill 4,20x14 guided (FAB-1687/19) Countersink 14 / 34 - steel (FAB-1694) Lab Analogue 34TL (008.342) Cylindrical drill 2,80x14 guided (FAB-1687/09) Lab Analogue 12 (008.112) Countersink 16- steel (00316) Cylindrical drill 3,50x8 guided (FAB-1687/11) Cylindrical drill 2,80x16 guided (FAB-1687/10) Countersink 14- ceramic (00414) Twist drill 3.5 mm -ceramic (00204) Transporter 12 -ceramic (00612) Cylindrical drill 2,00x16 guided (FAB-1687/05) Fixation Pin 1.5 Guided (PIN-1) Transporter 12 -steel (00512) Cylindrical drill 2,80x8 guided (FAB-1687/06) Transporter 16 long -ceramic (00616) Countersink 11- steel (00311) Transporter 16 short -steel (00517-S) Lab Analogue 16 (008.116) Initial bur/ positioner / triangle -steel (00101) Mallet for implant 14 -steel/plastic (005.114) Twist drill 2.8 mm -ceramic (00203) Cylindrical drill 3,50x18 guided (FAB-1688/03) Lab Analogue 34L (008.234) Transporter TL -ceramic (006.342) Countersink 16 - steel (FAB-1697) Cylindrical drill 4,20x12 guided (FAB-1687/18) Countersink 21 - steel (FAB-1695) Countersink 21- ceramic (00421) Lab Analogue 11 (008.111) Cylindrical drill 3,50x14 guided (FAB-1687/14) Lab Analogue 42 (008.142) Transporter 16 short -steel (00517) Twist drill 2.3 mm -steel (00102) Torque Wrench Kit CeraRoot (03001) Cortical drill guided (FAB-1707) Cylindrical drill 2,80x10 guided (FAB-1687/07) Cylindrical drill 2,80x18 guided (FAB-1688/02) Countersink 16- ceramic (00416) Countersink 21- steel (00321) Contra Angle Driver 4x4 (ACE-8) Ceramic Tray (02004) Cylindrical drill 2,00x18 guided (FAB-1688/01) Cylindrical drill 3,50x12 guided (FAB-1687/13) Lab Analogue 34 (008.134) Cylindrical drill 2,80x12 guided (FAB-1687/08) Guided Surgical Tray (02002) Cylindrical drill 3,50x10 guided (FAB-1687/12) Transporter 11 short -ceramic (006.111) Cylindrical drill 4,20x16 guided (FAB-1687/20) Transporter 34 -steel (00534) Initial drill short guided (FAB-1706/01) Twist drill 3.5 mm -steel (00104) Lab Analogue 21TL (008.212) Transporter 21 -ceramic (00621) Surgical Tray (02001) Twist drill 2.8 mm -steel (00103) Twist drill 4.2 mm -steel (00105) Cylindrical drill 2,00x12 guided (FAB-1687/03) Cylindrical drill 4,20x8 guided (FAB-1687/16) Transporter 21 -steel (00521)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-01-10
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2019-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

Xavier Oliva Business: CeraRoot USA Inc. Email: info@ceraroot.com Phone: (818) 4504776

Related Public Records

Same Entity

CERAROOT S.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008808095. Last updated year: 2026. Please use registration number 3008808095 when referencing this establishment in official correspondence.