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FDA 510(k)

MAX-I-PROBE HANDPIECE

K-Number: K851944 · 1985-07-01

ApplicantSolo Pak Laboratories
Decision Date1985-07-01
Product CodeEIC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAX-I-PROBE HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Solo Pak Laboratories. It received FDA 510(k) clearance on 1985-07-01 under 510(k) number K851944. The device is classified under product code EIC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAX-I-PROBE HANDPIECE?

MAX-I-PROBE HANDPIECE is a medical device that received FDA 510(k) clearance on 1985-07-01. The listed applicant is Solo Pak Laboratories. The 510(k) number is K851944.

When did MAX-I-PROBE HANDPIECE receive FDA 510(k) clearance?

MAX-I-PROBE HANDPIECE received FDA 510(k) clearance on 1985-07-01, under 510(k) number K851944.

Who is the listed applicant for MAX-I-PROBE HANDPIECE?

The FDA 510(k) record lists Solo Pak Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAX-I-PROBE HANDPIECE?

The FDA product code for MAX-I-PROBE HANDPIECE is EIC.

Related Clinical Trials

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.

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Other records listing Solo Pak Laboratories 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.

K841306HEPARIN LOCK FLUSH SOLUTION USP KIT,100K841166HEPARIN LOCK FLUSH PROCEDURE PACKK841305HEPARIN LOCK FLUSH SOLUTION USP KIT

Related Devices (Code: EIC)

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.

K972234RCT GEL ROOT CANAL THERAPY GELDentsply Intl.K864307MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)Smith & Nephew, Inc.K861846HYDRON ROOT CANAL FILLING & MARK IV STARTER KITSolar Dental Co., Inc.K840237MAX-I-PROBE PERIODONTAL ENDODONTIC PROBSmith & Nephew, Mpl DivisionK811889R & S SERIES FITTING TOOLSSuncoast Dental Corp.K811594WATER PISTOLAus-Tex Dental Mfg. & Design

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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