FDA Registration
Active
🇺🇸 United States
Dentsply Sirona Orthodontics Inc.
Reg #: 1036212
·
FEI: 1036212
·
Expires 2026
Products
19
Proprietary Names
52
Establishment Types
4
Classifications
19
Registration Details
- Registration Name
- Dentsply Sirona Orthodontics Inc.
- Registration Number
- 1036212
- FEI Number
- 1036212
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7290 26th Court East
- City
- Sarasota
- State
- FL
- ZIP
- 34243
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062828
Owner / Operator
- Firm Name
- DENTSPLY SIRONA INC
- Operator Number
- 2511302
- Address
- 221 WEST PHILADELPHIA ST., SUITE 60W
- City
- York
- State
- PA
- Postal Code
- 17401
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2006-02-28 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 1996-05-01 |
| Aligner, Beam, X-Ray | EHA | Class 1 | Dental | No | 2008-02-19 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2006-12-04 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2006-12-04 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2006-12-04 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2006-12-04 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2006-03-16 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2002-03-18 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 1992-08-12 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2011-04-01 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2006-06-12 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2005-12-28 |
| Dental Prophylaxis Kit | NYC | Class 1 | Dental | No | 2018-05-15 |
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2003-10-02 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 1992-08-12 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 1979-02-20 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 1992-08-12 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2022-12-13 |
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
Aquasil Ultra Cordless digit Power Dispenser
digit Syringe Dispenser
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device