SparkTM Clear Aligner System
Ormco Corporation · Dental
Open FDA's page for this record- Third party flag
- Y
- City
- Brea
- Advisory committee description
- Dental
- Address 1
- 200 S. Kraemer Blvd.
- Statement or summary
- Summary
- Product code
- NXC
- Zip code
- 92821
- Applicant
- Ormco Corporation
- Decision date
- 2025-02-20
- Decision code
- SESE
- Country code
- US
- Device name
- SparkTM Clear Aligner System
- Advisory committee
- DE
- Contact
- Jessica Pomares
- K number
- K250487
- State
- CA
- Date received
- 2025-02-19
- Review advisory committee
- DE
- Postal code
- 92821
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Aligner, Sequential
- Medical specialty description
- Dental
- Regulation number
- 872.5470
- Device class
- 2
- Registration number
- 3025029555, 3035691085, 1410097, 3005985361, 3008882689, 1036212, 1032227, 3014701704, 1937100, 3030255892, 3012138716, 3010881820, 3017220679, 2953749, 3006430881, 3004086183, 3033508190, 1054415, 3033492726, 3009482106, 3015674959, 3033273840, 3004158247, 3027500898, 3008261720, 3007233968, 3013556527, 3004793856, 9680845, 3008475975, 3018126402, 3045535064, 3022727952, 3035484470, 3002706372, 3042641209, 3015456817, 3003402534, 3032193293, 3025237243 +62 more
- FEI number
- 3025029555, 3035691085, 3002519584, 1410097, 3005985361, 3008882689, 1036212, 1032227, 3014701704, 1937100, 3030255892, 3012138716, 3010881820, 3017220679, 3006430881, 3004086183, 3033508190, 3033492726, 3009482106, 3015674959, 3033273840, 3004158247, 3027500898, 3008261720, 3007233968, 3001947560, 3013556527, 3004793856, 3008475975, 3018126402, 3045535064, 3022727952, 3035484470, 3002706372, 3042641209, 3003069616, 2024258, 3015456817, 3003402534, 3032193293 +62 more