(35 days)
PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.
PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. PULPDENT Endo-Prep II will be offered in two viscosities, thin and thick, so that the dentist can apply the product either directly to the canal ovening or to the file.
This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS DATA" for a dental product called PULPDENT Endo-Prep II, which is a chelating agent used in root canal procedures.
The document focuses on comparing PULPDENT Endo-Prep II to predicate devices, stating its substantial equivalence in composition and intended use. It references a publication by the American Dental Association regarding the general effectiveness of EDTA as a chelating agent.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study based on the provided text, as this information is not present.
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EXHIBIT 7
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA.
TELEPHONE: (617) 926-6666 (617) 926-6262 FAX:
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1961089
PULPDENT Endo-Prep II DEVICE NAME:
Ultradent File-Eze PREDICATE DEVICES: Premier RC Prep Roth REDTA Chelating Agent Union Broach Endodilator N-O
DESCRIPTION AND INTENDED USE: PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. PULPDENT Endo-Prep II will be offered in two viscosities, thin and thick, so that the dentist can apply the product either directly to the canal ovening or to the file.
COMPARISON WITH PREDICATE PRODUCTS: PULPOENT Endo-Prep II is substantially equivalent in composition and intended use as the products. Please see Exhibit 5 for the entire comparison.
SAFETY AND EFFECTIVENESS: According to Accepted Dental Thercepentics, which is a publication of the Council on Dental Therapeutics of the American Dental Association, a buffered, aqueous solution of EDTA (ethylenediaminetetraacetic acid) " .. very strongly binds or chelates heavy metal ions, [such as calcium] ... [EDTA] may be used as an aid in preparing root canals which resist enlargement by mechanical means."
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EXHIBIT 5
COMPARISON TABLE OF PULPDENT ENDO-PREP II AND PREDICATE PRODUCTS
| PARAMETER | PULPDENT Endo-Prep II | PREDICATE PRODUCTS | PRE-AMENDMENTOR 510(k) |
|---|---|---|---|
| Chelating agent | Disodium salt ofethylendiaminetetraaceticacid dihydrate (EDTA) | Ultradent File-EzePremier RC PrepRoth REDTA ChelatingAgentUnion Broach MoycoEDTAPulpdent Endo-PrepPulpdent EDTAPreparations | K934415Pre-amendmentPre-amendmentK950365K896663K932791 |
| Buffered watersoluble base | Thin and thick formula | Ultradent File-EzePremier RC PrepRoth REDTA ChelatingAgentUnion Broach MoycoEDTAPulpdent Endo-PrepPulpdent EDTAPreparations | K934415Pre-amendmentPre-amendmentK950365K896663K932791 |
| Polyethyleneglycol carrier | Thick formula | Pulpdent Endo-PrepPulpdent EDTAPreparationsUltradent File-EzePremier RC Prep | K896663K932791K934415Pre-amendment |
| Intended use | Chelating agent fordebriding and clearing theroot canal duringendodontic procedures.EDTA aids in the filingprocess by chelating calciumfrom dentin | Ultradent File-EzePremier RC PrepRoth REDTA ChelatingAgentUnion Broach MoycoEDTAPulpdent Endo-PrepPulpdent EDTAPreparations | K934415Pre-amendmentPre-amendmentK950365K896663K932791 |
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§ 872.3840 Endodontic silver point.
(a)
Identification. An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the root canal of a tooth.(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.