510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dentall, Inc.

District, Beijing, CN

DENTALL, INC. appears in FDA device records in District, Beijing, CN. FDA records list 3 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
0
Registered establishments
3

510(k) clearance history

FDA records hold 3 510(k) clearances for Dentall, Inc. between 2006 and 2017. The busiest year on record is 2006, with 1. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dentall, Inc., by decision year
YearClearances
20061
20151
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K170529Delight, Delight ortho, B&Lite SEBZSubstantially Equivalent
K140432HI-LIGHT, HI-LIGHT PLUSEBZSubstantially Equivalent
K061658SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, LEBZSubstantially Equivalent

Registered establishments

FDA registered establishments for Dentall, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30093076353009307635DENTALL Co., Ltd.301-905, Bucheontechnopark, 345, Bucheon-si Gyeonggi 14501 KR2026
30057358593005735859DENTALL, INC.THE STANDARD WORKSHOP,TIAN-ZHU, DISTRICT, BEIJING 101312 CN2026and 1 more, listed in full below
30128109373012810937DENTALL, INC.1245 Milwaukee Ave. Ste #306, Glenview, IL 60025 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain