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

Daegu, KR

DENTIS CO., LTD. appears in FDA device records in Daegu, KR. FDA records list 37 510(k) clearances between and , no PMA records and 2 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
37
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 37 510(k) clearances for Dentis Co.,Ltd between 2008 and 2026. The busiest year on record is 2023, with 9. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dentis Co.,Ltd, by decision year
YearClearances
20081
20092
20121
20152
20163
20173
20181
20202
20216
20221
20239
20244
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253493Dentis SQ-SL AXEL FixtureDZESubstantially Equivalent
K241065ChecQ (AC100)EKXSubstantially Equivalent
K233921Luvis Chair (LC700C)KLCSubstantially Equivalent
K241063s-Clean ScanHealing AbutmentNHASubstantially Equivalent
K240511Dentis s-Clean SQ-SL FixtureDZESubstantially Equivalent
K233544MESHEETNXCSubstantially Equivalent
K230126Dentis s-Clean Regular AbutmentNHASubstantially Equivalent
K230307Dentis i-Clean SystemNHASubstantially Equivalent
K230246Dentis s-Clean SQ-SL Narrow Implant SystemNHASubstantially Equivalent
K230523s-Clean Link Abutment NarrowNHASubstantially Equivalent
K230203Dentis I-FIX AbutmentNHASubstantially Equivalent
K222367SAVE GBRDZLSubstantially Equivalent
K222451SAVE GBRNHASubstantially Equivalent
K222913s-Clean Link AbutmentNHASubstantially Equivalent
K222976MU SystemNHASubstantially Equivalent
K220440Dentis s-Clean Abutment MiniNHASubstantially Equivalent
K210410s-Clean Pre-Milled Abutment MiniNHASubstantially Equivalent
K210362s-Clean Pre-Milled AbutmentNHASubstantially Equivalent
K210080Dentis s-Clean s-Line MiniDZESubstantially Equivalent
K210134Dentis s-Clean s-LineDZESubstantially Equivalent
K202773s-Clean SQ-SL Implant System MiniDZESubstantially Equivalent
K210132s-Clean SQ-SL Implant System RegularDZESubstantially Equivalent
K200099s-Clean SQ-SL Implant System MiniDZESubstantially Equivalent
K192688s-Clean SQ-SL Implant System RegularDZESubstantially Equivalent
K180657Resin for Temporary Crown & BridgeEBGSubstantially Equivalent
K171694s-Clean TiN Coating AbutmentsNHASubstantially Equivalent
K171027Dentis Dental Implant SystemDZESubstantially Equivalent
K170220OneQ-SL s-Clean Implant SystemDZESubstantially Equivalent
K161244s-Clean OneQ-SL Narrow Implant SystemDZESubstantially Equivalent
K160213s-Clean Tapered II RBM Implant SystemDZESubstantially Equivalent
K153639OneQ-SL s-Clean Implant SystemDZESubstantially Equivalent
K142313OneQ-SL Implant SystemDZESubstantially Equivalent
K150344Dentis Dental Implant SystemDZESubstantially Equivalent
K111364HAPTITE COATING IMPLANT SYSTEMDZESubstantially Equivalent
K082843MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K083586I-FIX SYSTEMDZESubstantially Equivalent
K073486DENTIS DENTAL IMPLANT SYSTEMDZESubstantially Equivalent

Registered establishments

FDA registered establishments for Dentis Co.,Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30070310983007031098DENTIS CO., LTD.99, Seongseoseo-ro, Dalseo-Gu, Daegu 42718 KR2026
30361905113036190511Dentis Co.,Ltd87, Yuram-ro, Dong-gu Daegu 41059 KR2026

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