510(k) clearances

RAYDENT SW

Ray Co., Ltd. · Dental

K233625Substantially EquivalentTraditionalPNN
Open FDA's page for this record
Third party flag
N
City
Yongin-Si
Advisory committee description
Dental
Address 1
1f~3f, 4f(Part), 5f, 265, Daeji-Ro, Suji-Gu
Statement or summary
Summary
Product code
PNN
Zip code
16882
Applicant
Ray Co., Ltd.
Decision date
2024-05-16
Decision code
SESE
Country code
KR
Device name
RAYDENT SW
Advisory committee
DE
Contact
Huh Soo Ji
K number
K233625
Date received
2023-11-13
Review advisory committee
DE
Postal code
16882
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Orthodontic Software
Medical specialty description
Dental
Regulation number
872.5470
Device class
2
Registration number
3029877582, 3004884150, 3017545364, 3042369188, 3014749460, 3005940400, 3013508670, 9680845, 3031606517, 3005695824, 3012138716, 9614977, 3018126402, 3007527669, 2953749, 3013634985, 3026391019, 3045923493, 3028340833, 3014680924, 3013342228, 3013912897, 3042204491, 3033714666, 3016730274, 3025359603, 1054415, 1649995, 3015272949, 3010445368, 3017155477, 3021551875, 3003402534, 3010728558, 3008910197, 3024438491, 3010111497, 3025237243, 3027460334, 3016446349 +2 more
FEI number
3003719498, 3029877582, 3004884150, 3002519584, 3017545364, 3042369188, 3014749460, 3001947560, 3000368601, 3005940400, 3031606517, 3005695824, 3012138716, 3018126402, 3007527669, 3013634985, 3026391019, 3045923493, 3028340833, 3014680924, 3013342228, 3013912897, 3042204491, 3033714666, 3016730274, 3025359603, 3015272949, 3003069616, 3010445368, 2024258, 3017155477, 3021551875, 3003402534, 3010728558, 3008910197, 3024438491, 3010111497, 3025237243, 3027460334, 3016446349 +2 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.