510(k) clearances

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

Dci International, LLC · Dental

K250473Substantially EquivalentTraditionalEIA
Open FDA's page for this record
Third party flag
Y
City
Newberg
Advisory committee description
Dental
Address 1
705 S Springbrook Rd.
Address 2
Bldg. C
Statement or summary
Statement
Product code
EIA
Zip code
97132
Applicant
Dci International, LLC
Decision date
2025-02-19
Decision code
SESE
Country code
US
Device name
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
Advisory committee
DE
Contact
Dana Shusterman
K number
K250473
State
OR
Date received
2025-02-19
Review advisory committee
DE
Postal code
97132
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Unit, Operative Dental
Medical specialty description
Dental
Regulation number
872.6640
Device class
1
Registration number
1523530, 3014479313, 3002807636, 8044167, 2520265, 3010707607, 9614446, 8030876, 3013734432, 1054713, 3008813313, 3043226252, 3007997036, 3003548115, 9681479, 3033509898, 3023861999, 3007518359, 3021741513, 3008770655, 3004961419, 1722021, 3003508094, 3010141593, 2081055, 3010373494, 2020475, 2648666, 3015376465, 3036756245, 3005082946, 3009797758, 3029780, 3003637274, 3019103, 3017604, 3030089804, 9610617, 8040233, 3012421607 +72 more
FEI number
1523530, 3014479313, 3002807636, 2520265, 1000523896, 3010707607, 3004084693, 3013734432, 3008813313, 3043226252, 3007997036, 3003548115, 3033509898, 3002808268, 3003755849, 3023861999, 3007518359, 3021741513, 3008770655, 3004961419, 3003508094, 3010141593, 2081055, 3010373494, 2020475, 2648666, 3015376465, 3036756245, 3005082946, 3009797758, 3003637274, 3019103, 3017604, 3030089804, 3012421607, 2023950, 1018470, 3004082121, 3009774128, 3001947560 +72 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.