Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222802

FEI Number

1000120733

Entity Name

DENTSPLY IH Inc.

City/State/Country

Waltham, MA, US

Establishment Address

590 LINCOLN STREET, Waltham, MA 02451, US

Establishment Type(s)

Manufacture Medical Device

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

Expiration Date (Year)

2026

510(k) Number

K130216

PMA Number

N/A

All Registered Proprietary Names

Atlantis Temp Crown ATLANTIS Crown

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	2017-10-27
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2006-08-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-09-15
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	2017-10-27
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2001-10-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-07-17
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
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-04-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-03-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-12-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-11-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-12-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222802. Last updated year: 2026. Please use registration number 1222802 when referencing this establishment in official correspondence.