Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005914490

FEI Number

3005914490

Entity Name

UNIDADE DE ESTERILIZACAO COTIA LTDA.

City/State/Country

Cotia Sao Paulo, BR

Establishment Address

Av. Cruzada Bandeirantes/ N 29 0, Cotia Sao Paulo 06705-140, BR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Sotera Health LLC (Owner Number: 10029425)

Owner / Operator Contact Address

2015 Spring Road, Suite 650, Oak Brook, IL 60523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

560 ISO S P P C C E W144 140 560 ISO S P P C C E W144 90 - 140 LEXICON ABS S P P ISO W180 15 565 AUXILIARY S P P W144 X C 560 ISO S P P C C E W180 50 560 ISO S P P C C E W180 35 ABSORBENT S P P MAILLEFER W180 60 560 ISO S P P C C E W180 40 560 ISO S P P C C E W180 15 - 40 560 ISO S P P C C E W180 30 LEXICON ABS S P P ISO W180 45-80 ABSORBENT S P P MAILLEFER W180 XXF-XC ABSORBENT S P P MAILLEFER W180 70 LEXICON ABS S P P ISO W180 15-40 560 ISO S P P C C E W180 20 ABSORBENT S P P MAILLEFER W180 F ABSORBENT S P P MAILLEFER W180 C 565 AUXILIARY S P P W180 F 560 ISO S P P C C E W180 15 560 ISO S P P C C E W180 45 560 ISO S P P C C E W144 90 560 ISO S P P C C E W144 100 LEXICON ABS S P P ISO W180 20 LEXICON ABS S P P ISO W180 25 ABSORBENT S P P MAILLEFER W180 XF LEXICON ABS S P P W180 F ABSORBENT S P P MAILLEFER W180 55 LEXICON ABS S P P ISO W180 55 565 AUXILIARY S P P W180 XXF-C 560 ISO S P P C C E W144 130 560 ISO S P P C C E W180 25 ABSORBENT S P P MAILLEFER W180 20 ABSORBENT S P P MAILLEFER W180 30 LEXICON ABS S P P ISO W180 50 560 ISO S P P C C E W180 80 ABSORBENT S P P MAILLEFER W180 M LEXICON ABS S P P W180 XF LEXICON ABS S P P W180 XXF-XC ABSORBENT S P P MAILLEFER W180 15-40 ABSORBENT S P P MAILLEFER W180 15 560 ISO S P P C C E W180 70 ABSORBENT S P P MAILLEFER W180 45 560 ISO S P P C C E W180 60 565 AUXILIARY S P P W180 M ABSORBENT S P P MAILLEFER W180 35 560 ISO S P P C C E W180 55 LEXICON ABS S P P ISO W180 40 ABSORBENT S P P MAILLEFER W180 25 LEXICON ABS S P P ISO W180 80 ABSORBENT S P P MAILLEFER W180 XC LEXICON ABS S P P W180 M LEXICON ABS S P P ISO W180 30 ABSORBENT S P P MAILLEFER W180 50 ABSORBENT S P P MAILLEFER W180 40 ABSORBENT S P P MAILLEFER W180 80 565 AUXILIARY S P P W180 XX F 560 ISO S P P C C E W144 110 LEXICON ABS S P P W180 X-C LEXICON ABS S P P ISO W180 70 LEXICON ABS S P P W180 C LEXICON ABS S P P ISO W180 45 565 AUXILIARY S P P W180 C LEXICON ABS S P P ISO W180 60 560 ISO S P P C C E W144 120 560 ISO S P P C C E W180 45 - 80 ABSORBENT S P P MAILLEFER W180 45-80 LEXICON ABS S P P ISO W180 35 565 AUXILIARY S P P W180 X F Precise Dental

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2013-01-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-12-16
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-12-16
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2021-12-16
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-12-16

Official Correspondent

Karen Whaley-Krumins

US Agent Details

Chris Eustace Email: ceustace@sterigenics.com Phone: (630) 9281700

Related Public Records

Same Entity

Sotera Health LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680579	Sterigenics Radiation Technologies Canada, Inc	PORT COQUITLAM British Columbia, CA
3008132411	Sterigenics Shanghai E Beam Ltd.	Shanghai, CN
9616517	Sterigenics S. de R.L. de C.V.	Tepeji del Rio de Ocampos Hidalgo, MX
3008328679	Sterigenics S. de R.L. de C.V.	Cuautitlan Izcalli Mexico, MX
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

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 3005914490. Last updated year: 2026. Please use registration number 3005914490 when referencing this establishment in official correspondence.