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K Number
K980783
Device Name
SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5
Manufacturer
IRT MANAGEMENT CORP.
Date Cleared
1998-04-21

(50 days)

Product Code
KHR
Regulation Number
872.6050
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

General Usage:

For the absorption/Collection and removal of excessive saliva during dental procedures.

For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth.

For the absorption/Collection and removal of saliva in General Pediatric Use.

For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers.

For the absorption and removal of saliva when typical "suction" type devices are not appropriate or effective. ...

For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.

Device Description

SIMPLEX™ SALIVA ABSORBER/COLLECTOR

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, discussing the substantial equivalence of a device (Simplex Saliva Absorber/Collector) to pre-existing devices. It explicitly states that the device is of regulatory class I.

Therefore, the document does not contain information about:

  • Acceptance criteria and reported device performance.
  • A study proving the device meets acceptance criteria.
  • Sample sizes for test sets or training sets.
  • Data provenance or adjudication methods.
  • Expert qualifications or number of experts used to establish ground truth.
  • Multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used.

The letter is a regulatory approval document based on substantial equivalence to a predicate device, not a detailed technical study report.

§ 872.6050 Saliva absorber.

(a)
Identification. A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.