Dentsply Sirona Orthodontics Inc.

FDA Device Registration & Listing · RICHARDSON, TX, US · Registration 1649995

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
1649995
FEI Number
3001947560
Entity Name
Dentsply Sirona Orthodontics Inc.
City/State/Country
RICHARDSON, TX, US
Establishment Address
1125 E Campbell Rd Ste 100, RICHARDSON, TX 75081, 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
N
Expiration Date (Year)
2026
510(k) Number
K171860
PMA Number
N/A

All Registered Proprietary Names

SureSmile Advanced Software v 7.6 SureSmile Ortho Software v 7.6 SureSmile Aligner Software v 7.6 SureSmile Wires SureSmile Aligner Transfer Tray SureSmile Aligner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QJJ Indirect Bonding Tray Dental Class 1 872.5410 2022-12-13
EIA Unit, Operative Dental Dental Class 1 872.6640 2019-12-16
DZC Wire, Orthodontic Dental Class 1 872.5410 1992-08-12
OFX General Purpose Dental Tray Dental Class 1 872.6640 2022-11-04
NXC Aligner, Sequential Dental Class 2 872.5470 2019-12-16

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

Similar Registrations

Registration Number Establishment Name Location
3015341209 ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO.,LTD Jiaxing City Zhejiang, CN
3014680794 JOHNS DENTAL LABORATORY Terre Haute, IN, US
3008261720 JJGC Industria e Comercio de Materiais Dentarios SA Curitiba Parana, BR
3005695824 Align Technology de Costa Rica S.R.L Belen Heredia, CR
1000118628 FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. Denton, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649995. Last updated year: 2026. Please use registration number 1649995 when referencing this establishment in official correspondence.
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