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FDA 510(k)

SATALEC PIEZOTEC

K-Number: K852525 · 1986-01-30

ApplicantSpelna, Inc.
Decision Date1986-01-30
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SATALEC PIEZOTEC is the device name listed in this FDA 510(k) record. The listed applicant is Spelna, Inc.. It received FDA 510(k) clearance on 1986-01-30 under 510(k) number K852525. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATALEC PIEZOTEC?

SATALEC PIEZOTEC is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is Spelna, Inc.. The 510(k) number is K852525.

When did SATALEC PIEZOTEC receive FDA 510(k) clearance?

SATALEC PIEZOTEC received FDA 510(k) clearance on 1986-01-30, under 510(k) number K852525.

Who is the listed applicant for SATALEC PIEZOTEC?

The FDA 510(k) record lists Spelna, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SATALEC PIEZOTEC?

The FDA product code for SATALEC PIEZOTEC is ELC.

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Other records listing Spelna, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K852527SATALEC SEPTOSONIC SC 80/SC 120K852522SATALEC SERVOTOMEK8532005X2 SATALEC CHIROPODY CASEK852521SATLEC PROPHY UNIT PU 3055K852524SATALEC SERVOTORQUE S2 SX2K832664SATELEC SUPRASSON PIEZOMATIC P2

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Related Devices (Code: ELC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)Nakanishi, Inc.K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)Shenzhen Micro Electric Intelligence Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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