Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1036212

FEI Number

1036212

Entity Name

Dentsply Sirona Orthodontics Inc.

City/State/Country

Sarasota, FL, US

Establishment Address

7290 26th Court East, Sarasota, FL 34243, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Snap-A-Ray® Film Holder Uni-Grip® Universal Radiography Holder BAI Bite-Block film holders Rinn Digital Sensor Covers Flip-Ray XCP-DS FIT® Sensor Holder Rinn® Digital Sensor Loops XCP-DS® Digital Sensor Replacement Baskets and Bite Blocks XCP-DS® Replacement Bitepieces Uni-Grip® 360 Universal Sensor Holder Eezee-Grip® Digital Sensor Holder Silicone BW #2 Film Holder EndoRay® II Endodontic Film Holder Snap-A-Ray® DS for Sensors XCP® / XCP-ORA® Film Positioning Kits Adhesive Comfort Tab for Film -Cover Cozee® BAI Instrument Kits Bite-Wing Loops film holders Bite-Wing Instrument Kits RINN® XCP-ORA® Cover Cozee Sensor Cover Tamer XCP® Disposable Bite-Blocks (film holders) Bite-Wing Bite-Blocks film holders Uni-Bite® Universal Film Holder Cover Cozee Comfort Solution XCP-DS® Digital Sensor Positioning Kits Rinn® Loops Schick CDR Elite Sensor Holder Cover Cozee BW Rinn® Cover-Cozee® Sensor Cover Tamer Stabe® Disposable Film Holders Adhesive Bite-Wing Tabs XCP®, BAI & XCP-DS® Stainless Steel Indicator Arms XCP-DS® Sensor Holder X-Ray Exposure Alignment (XCP® / XCP-ORA®) Uni-GRIPAR® Essix PLUS Essix Tray-Rite Tray Material Essix A+ Essix (Sports) Mouthguard Essix ACE Essix C+ Nightguard Laminate (M); Essix Dual Laminates Essix Nightguard Laminate FLASHTIPS SureSmile Wires Flex-View Interproximal Strips Interproximal Serrated Strips SureSmile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2006-02-28
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	1996-05-01
EHA	Aligner, Beam, X-Ray	Dental	Class 1	872.1820	2008-02-19
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2006-12-04
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2006-12-04
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2006-12-04
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2006-12-04
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2006-03-16
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2005-03-01
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2002-03-18
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	1992-08-12
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2011-04-01
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2006-06-12
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2005-12-28
NYC	Dental Prophylaxis Kit	Dental	Class 1	872.4565	2018-05-15

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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1036212. Last updated year: 2026. Please use registration number 1036212 when referencing this establishment in official correspondence.