Wellspect Healthcare

FDA Device Registration & Listing · Molndal Vastra Gotaland, SE · Registration 3009632672

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
3009632672
FEI Number
3009632672
Entity Name
Wellspect Healthcare
City/State/Country
Molndal Vastra Gotaland, SE
Establishment Address
Aminogatan 1, Molndal Vastra Gotaland SE-43121, SE
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
DENTSPLY SIRONA INC (Owner Number: 2511302)
Owner / Operator Contact Address
221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Implant catheter PrimeTaper

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-04-19
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2012-12-12
OUG Medical Device Data System General Hospital Class 1 880.6310 2019-12-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2011-12-16
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-11-20
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2001-10-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2013-01-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-11-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-11-20
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2022-02-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-12-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 2011-12-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2023-12-14
EZC Catheter, Coude Gastroenterology, Urology Class 2 876.5130 2023-05-08
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2023-05-08
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2023-12-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-12-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-12-07
NZU Collector, Urine, Powered, Non Indwelling Catheter Gastroenterology, Urology Class 1 876.5250 2025-11-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-08-27
FCE Enema Kit Gastroenterology, Urology Class 1 876.5210 2019-12-06
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2019-12-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-12-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA 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
9612618 DEGUDENT GMBH Rosbach V.D.H. Hesse, DE
3003756493 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR
3001226627 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) ST. EGREVE Isere, FR
3003136642 OraMetrix GmbH Berlin Brandenburg, DE
3000303964 DENTSPLY DENTAL (TIANJIN) CO., LTD. TEDA Tianjin, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009632672. Last updated year: 2026. Please use registration number 3009632672 when referencing this establishment in official correspondence.
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