BruxZir® Esthetic NOW
Prismatik Dentalcraft, Inc. · Dental
Open FDA's page for this record- Third party flag
- N
- City
- Irvine
- Advisory committee description
- Dental
- Address 1
- 2144 Michelson Dr.
- Statement or summary
- Summary
- Product code
- EIH
- Zip code
- 92612
- Applicant
- Prismatik Dentalcraft, Inc.
- Decision date
- 2025-02-25
- Decision code
- SESE
- Country code
- US
- Device name
- BruxZir® Esthetic NOW
- Advisory committee
- DE
- Contact
- So Hyun Park
- K number
- K250223
- State
- CA
- Date received
- 2025-01-27
- Review advisory committee
- DE
- Postal code
- 92612
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Powder, Porcelain
- Medical specialty description
- Dental
- Regulation number
- 872.6660
- Device class
- 2
- Registration number
- 3030515618, 3020611371, 3018252381, 3004362235, 1410097, 3030464310, 3034244245, 3011824442, 3014945384, 3009409473, 3003449480, 8010711, 3006110126, 3008912871, 2023129, 3017619362, 3002808149, 2433919, 2082832, 3024792419, 3024185724, 3004491043, 3022068322, 3009482106, 2647456, 3008754429, 1219645, 3034605324, 9613348, 3004905070, 2244842, 3031841433, 3031595584, 3027341558, 3004966444, 9612352, 3007738736, 3044771104, 3007160911, 3012187973 +124 more
- FEI number
- 3030515618, 3020611371, 3018252381, 3004362235, 1410097, 3030464310, 3034244245, 3011824442, 3014945384, 3009409473, 3003449480, 3006110126, 3002806930, 3008912871, 2023129, 3017619362, 3002808149, 3009523116, 2433919, 2082832, 3024792419, 3024185724, 3003999430, 3004491043, 3022068322, 3009482106, 2647456, 3008501562, 3008754429, 1219645, 3034605324, 3004905070, 3000206706, 2244842, 3031841433, 3031595584, 3027341558, 3004966444, 3007738736, 3044771104 +124 more