510(k) K250771
- Device
- Primescan 2
- Applicant
- Dentsply Sirona, Inc.
- 510(k) number
- K250771
- Product code
- NTK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-29
- Date received
- 2025-03-13
- Regulation
- 872.1745
- Classification name
- Caries Detector, Laser Light, Transmission
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Diane Rutherford
- Address
- 221 W. Philadelphia St. Suite 60w York PA US 17401 17401
FDA Registration Numbers#
- 3003637274
- 3015509619
- 3015729
- 3003694926
- 9612352
- 3009496224
- 3004884150
- 3009142030
- 3012138716
- 9614977
- 3031697712
- 2953749
- 3009646999
- 3029904428
- 8030876
- 3005695824
- 3040278150
- 3006186796
- 2515379
- 3007113232
- 3001052305
- 3007527669
- 3043226252
Source Documents#
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| K193659 | iTero Element 5D | Align Technology, Inc. | 2020-03-20 |
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| K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | 2017-11-22 |
| K123402 | DIAGNOCAM | Kaltenbach & Voigt GmbH | 2013-09-24 |
| K071429 | TI2200 TRANSILLUMINATION CABLE | Kerr Corporation | 2007-09-10 |
| K062961 | MICROLUX TRANSILLUMINATOR | Addent, Inc. | 2007-02-08 |
| K060080 | DIAGNODENT 2190 WITH PERIODONTAL PROBE | Kavo Dental Corporation | 2006-02-08 |
| K043068 | DIFOTI USB 2.0 SYSTEM | Electro-Optical Sciences, Inc. | 2004-12-29 |