MTA CEMENTS

• K Number: K130125
• Device Name: MTA CEMENTS
• Manufacturer: S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN
• Date Cleared: 2013-07-24 ( 188 days)
• Product Code: KIF
• Regulation Number: 872.3820
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

MTA-B :
Repair of root perforations during root canal therapy
Root-end filings
Pulp capping
Repair of root canals as an apical plug during apexification
MTA-T :
Repair of root perforations during root canal therapy
Root-end filings
Pulp capping
Repair of root canals as an apical plug during apexification
MTA-XR:
Repair of root perforations during root canal therapy
Root-end filings
Pulp capping
Repair of root canals as an apical plug during apexification
MTA-XR Flow:
Repair of root perforations during root canal therapy
Pulp capping
Repair of root canals as an apical plug during apexification

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for "MTA Cements," outlining its indications for use and regulatory compliance. It does not include details on performance studies, sample sizes, expert qualifications, or ground truth establishment.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.