510(k) clearances

Integrated Endo System (Meet Endo-II)

Denjoy Dental Co., Ltd. · Dental

K242317Substantially EquivalentTraditionalELC
Open FDA's page for this record
Third party flag
N
City
Changsha
Advisory committee description
Dental
Address 1
F4, Bldg. A4, Lugu Medical Device Park, #229
Address 2
Guyuan Rd.
Statement or summary
Summary
Product code
ELC
Zip code
410205
Applicant
Denjoy Dental Co., Ltd.
Decision date
2025-02-13
Decision code
SESE
Country code
CN
Device name
Integrated Endo System (Meet Endo-II)
Advisory committee
DE
Contact
Chengfa Huang
K number
K242317
Date received
2024-08-05
Review advisory committee
DE
Postal code
410205
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Scaler, Ultrasonic
Medical specialty description
Dental
Regulation number
872.4850
Device class
2
Registration number
3004569445, 3013298431, 1413475, 8044167, 3033858988, 1032227, 3006750855, 2520265, 2243757, 3011944170, 3008912871, 3030405669, 3005972890, 3018783058, 1054713, 3016075921, 3010864832, 3042866301, 3008615394, 1419489, 3043226252, 9681479, 1422375, 3023861999, 3008770655, 2411797, 1941138, 9616762, 8032033, 2127132, 3015376465, 3012187973, 3005282635, 3029780, 3003637274, 3017604, 2424472, 8043962, 3012421607, 3022516928 +67 more
FEI number
3002820248, 3004569445, 3013298431, 1413475, 3033858988, 1000493876, 1032227, 3006750855, 2520265, 1000523896, 2243757, 3011944170, 3002948158, 3008912871, 3030405669, 3005972890, 3018783058, 3016075921, 3042866301, 3008615394, 1419489, 3043226252, 3003755849, 3023861999, 3008770655, 2411797, 1941138, 3008981576, 3008875470, 2127132, 3015376465, 3012187973, 3005282635, 3003637274, 3017604, 3012421607, 3022516928, 2416455, 3002806828, 1000160293 +67 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.