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

Daegu, KR

SAESHIN PRECISION CO., LTD. appears in FDA device records in Daegu, KR. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. 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
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Saeshin Precision Co., Ltd. between 2009 and 2026. The busiest year on record is 2015, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Saeshin Precision Co., Ltd., by decision year
YearClearances
20092
20101
20111
20121
20153
20181
20192
20201
20211
20221
20231
20242
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251407Motor Handpiece and Control Unit (SDI10)EBWSubstantially Equivalent
K233153Traus SSG10 Surgical SystemHBCSubstantially Equivalent
K232938Traus SSG30 Surgical SystemHBCSubstantially Equivalent
K221741TRAUS Air Dental HandpieceEFBSubstantially Equivalent
K212043TRAUS ENDOEKXSubstantially Equivalent
K201292TRAUS SIP20EBWSubstantially Equivalent
K192561TRAUS SUS20DZISubstantially Equivalent
K182892TRAUS Dental HandpiecesEGSSubstantially Equivalent
K181129STRONG Dental HandpiecesEGSSubstantially Equivalent
K171436STRONG Dental HandpiecesEGSSubstantially Equivalent
K151171TRAUS SUS10DZISubstantially Equivalent
K143418STRONG Dental HandpiecesEGSSubstantially Equivalent
K143411TRAUS ENDOEKXSubstantially Equivalent
K123695TRAUS SIP10EKYSubstantially Equivalent
K111616E-CUBEEKXSubstantially Equivalent
K100192STRONG DENTAL HANDPIECESEGSSubstantially Equivalent
K092758X-CUBEEBWSubstantially Equivalent
K092412STRONG IMPLANT HANDPIECESEFASubstantially Equivalent

Registered establishments

FDA registered establishments for Saeshin Precision Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30079588313007958831SAESHIN PRECISION CO., LTD.52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu 711-814 KR2026and 5 more, listed in full below

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

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