LogoFDA 510(k) Search
K Number
K050658
Device Name
RESO-PAC PERIODONTAL DRESSING
Manufacturer
HAGER WORLDWIDE, INC.
Date Cleared
2005-05-27

(74 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K881422,K864720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation.

Device Description

The product is a periodontal wound dressing. It is intended for use only by dental practitioners; and will not be offered for OTC use. It contains materials that pose no health hazard when used according to directions.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a device called "Reso-Pac," a periodontal wound dressing.

It primarily discusses:

  • The manufacturer and submitter details.
  • The product's intended use and substantial equivalence to predicate devices.
  • FDA's clearance of the device for marketing.
  • Regulatory requirements and contacts.
  • Indications for use.

There is no mention of:

  • Specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy).
  • Any study design, test sets, training sets, ground truth establishment, expert qualifications, or adjudication methods for evaluating the device's performance against such criteria.
  • A multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the input text.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.