510(k) clearances

Dental Barrier and Sleeves

Yongqing Huaguan Dental Instruments Factory · General, Plastic Surgery

K233918Substantially EquivalentTraditionalPEM
Open FDA's page for this record
Third party flag
N
City
Langfang
Advisory committee description
General, Plastic Surgery
Address 1
Intersection Of Ronghua Rd. And Siwei St.
Address 2
Yongqing Industrial Area
Statement or summary
Summary
Product code
PEM
Applicant
Yongqing Huaguan Dental Instruments Factory
Decision date
2024-05-09
Decision code
SESE
Country code
CN
Device name
Dental Barrier and Sleeves
Advisory committee
SU
Contact
ZengYan Wu
K number
K233918
Date received
2023-12-13
Review advisory committee
DE
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Dental Barriers And Sleeves
Medical specialty description
General, Plastic Surgery
Regulation number
878.4370
Device class
2
Registration number
3001052305, 3005665377, 2086043, 1051614, 3007046497, 3027234828, 2029234, 3017910185, 2424472, 3012664306, 8010908, 2437780, 3001468798, 3011824442, 9680887, 8010638, 3006847937, 3004046477, 2435946, 3015509619, 3011944170, 3004425647, 3024088964, 2320721, 3009307523, 2515379, 3044819802, 3015276580, 3009496224, 3010656982, 3015491448, 2024980, 3014345250, 2182318, 8032009, 1718912, 2183301, 1941138, 2511556, 3035858919 +11 more
FEI number
3001052305, 3005665377, 1051614, 3002808636, 3007046497, 3027234828, 3002718942, 3017910185, 3012664306, 3002088145, 3011824442, 3004724816, 3008439903, 3006847937, 3004046477, 3015509619, 3011944170, 1000554802, 3004425647, 3024088964, 3009307523, 2515379, 3044819802, 3000209941, 2000020733, 3015276580, 3009496224, 3010656982, 3000719964, 3001746544, 3015491448, 3014345250, 2182318, 1718912, 1000220911, 3001697252, 2183301, 1941138, 2511556, 3035858919 +11 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.