Reusable SmartPeg
Osstell AB · Dental
Open FDA's page for this record- Third party flag
- N
- City
- Goteborg
- Advisory committee description
- Dental
- Address 1
- Stampgaten 14
- Statement or summary
- Summary
- Product code
- EKX
- Zip code
- SE 411-01
- Applicant
- Osstell AB
- Decision date
- 2026-09-08
- Decision code
- SESE
- Country code
- SE
- Device name
- Reusable SmartPeg
- Advisory committee
- DE
- Contact
- Stellan Sundstroem
- K number
- K261987
- Date received
- 2026-06-12
- Review advisory committee
- DE
- Postal code
- SE 411-01
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Handpiece, Direct Drive, Ac-Powered
- Medical specialty description
- Dental
- Regulation number
- 872.4200
- Device class
- 1
- Registration number
- 3015136927, 3014683120, 3001082453, 3025599428, 3005581016, 3015729, 1722638, 3025873468, 1419489, 3007007357, 3007663058, 3010373494, 3014330970, 9614977, 9681479, 3006444232, 3009431661, 8030962, 3018783058, 3008812251, 3007345485, 2024949, 3005164841, 1054713, 3017399129, 3000219976, 2243757, 3008544850, 3004070020, 3002807636, 3008249935, 3016875543, 2183301, 1223843, 3008590661, 3013206323, 8010468, 2085199, 8010629, 3025764223 +52 more
- FEI number
- 3015136927, 5615, 3014683120, 3001082453, 3025599428, 1000160293, 3005581016, 3015729, 3025873468, 3000719964, 1419489, 3007007357, 3007663058, 3010373494, 3014330970, 3002088145, 3006444232, 3009431661, 1000139790, 3002807687, 3018783058, 3007345485, 2024949, 3005164841, 3017399129, 3000219976, 3003719498, 2243757, 3008544850, 3004070020, 3003755849, 3002807636, 3008249935, 3016875543, 2183301, 3002948158, 3008590661, 3013206323, 3025764223, 3004884150 +52 more