Dentsply Implants Manufacturing GmbH

FDA Device Registration & Listing · Hanau Hesse, DE · Registration 3013111692

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
3013111692
FEI Number
3013111692
Entity Name
Dentsply Implants Manufacturing GmbH
City/State/Country
Hanau Hesse, DE
Establishment Address
Rodenbacher Chaussee 4, Hanau Hesse 63457, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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 XiVe TG Cercon Abutments Ankylos Cercon Balance

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 2008-01-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
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
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-12-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2001-10-23
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-04-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-12-05
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 1984-08-15
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 2001-10-23
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 2011-12-16
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2016-12-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-12-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-06-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-12-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-07-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2014-01-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2014-10-14
JEY Plate, Bone Dental Class 2 872.4760 2008-01-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-03-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-21

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
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 3013111692. Last updated year: 2026. Please use registration number 3013111692 when referencing this establishment in official correspondence.
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