Data / Medical devices / United States / DENTSPLY IH Inc.

DENTSPLY IH Inc.: FDA-registered device maker in Waltham, MA, United States, 27 510(k) clearances

Name: DENTSPLY IH Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DENTSPLY IH Inc. is registered with the FDA (registration 1222802) in Waltham, MA, United States. It lists 5 device types. The FDA files 27 510(k) clearances under its listings, the newest dated December 9, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1222802
FEI number: 1000120733
Address: 590 Lincoln Street, Waltham, MA, United States, 02451
Owner or operator: DENTSPLY SIRONA INC (2511302)
Roles: Contract manufacturer, Manufacturer
First device listed: October 23, 2001
Registered through: 2027
Brand names listed: ATLANTIS Crown, Atlantis Abutment in Zirconia for 3i Certain MicroMini Implants, Atlantis Temp Crown

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Crown, Preformed	ELZ	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 9, 2025	K252343	Atlantis® Abutments in Titanium	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
November 21, 2025	K251205	Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
April 11, 2025	K250081	Atlantis® Abutments in Titanium	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
November 30, 2017	K172225	Atlantis Abutment for MIS Implant	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
August 29, 2016	K160626	ATLANTIS Abutment for HIOSSEN ET implant	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
January 29, 2016	K152247	ATLANTIS Crown	EIH	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
October 25, 2013	K130999	OSSEOSPEED PROFILE EV	DZE	Substantially Equivalent	Dentsply Implants Manufacturing GmbH	accessdata.fda.gov
May 1, 2013	K130216	ATLANTIS STRAUMANN BONE LEVEL ABUTMENT	NHA	Substantially Equivalent	Dentsply Implant	accessdata.fda.gov
January 23, 2013	K121810	OSSEOSPEED ANGLED ABUTMENT EV	NHA	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
July 5, 2012	K120338	ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
March 1, 2012	K113003	ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
December 1, 2011	K112138	ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
June 10, 2011	K110640	ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
June 10, 2011	K110356	ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
February 3, 2011	K103020	ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT	NHA	Substantially Equivalent	Atlantis Components, Inc.	accessdata.fda.gov
April 16, 2010	K093780	ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
December 22, 2009	K093483	ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
September 28, 2009	K091920	ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
April 15, 2009	K083871	ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
September 17, 2008	K080156	OSSEOSPEED TM PROFILE SYSTEM	DZE	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
February 29, 2008	K073540	ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT	NHA	Substantially Equivalent	Atlantis Components, Inc.	accessdata.fda.gov
November 16, 2007	K072483	ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS	NHA	Substantially Equivalent	Atlantis Components, Inc.	accessdata.fda.gov
October 5, 2007	K071946	ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS	NHA	Substantially Equivalent	Atlantis Components, Inc.	accessdata.fda.gov
March 2, 2007	K063734	ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE	NHA	Substantially Equivalent	Atlantis Components, Inc.	accessdata.fda.gov
December 20, 2006	K062277	ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE	NHA	Substantially Equivalent	Atlantis Components, Inc.	accessdata.fda.gov
March 3, 2006	K053450	ATLANTIS ABUTMENT FOR ZIMMER INTERFACE	NHA	Substantially Equivalent	Atlantis Components, Inc.	accessdata.fda.gov
October 14, 2005	K052070	ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA	NHA	Substantially Equivalent	Atlantis Components, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 24, 2025	97305	Class II	Ongoing	Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FL	The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.	accessdata.fda.gov

Compare with other makers

Updated December 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.