PULPDENT ENDOPREP II
K961089 · Pulpdent Corp. · EKL · Apr 23, 1996 · Dental
Device Facts
| Record ID | K961089 |
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| Device Name | PULPDENT ENDOPREP II |
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| Applicant | Pulpdent Corp. |
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| Product Code | EKL · Dental |
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| Decision Date | Apr 23, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 872.3840 |
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| Device Class | Class 1 |
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| Attributes | Therapeutic |
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Intended Use
PULPDENT Endo-Prep II is a 17% EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.
Device Story
PULPDENT Endo-Prep II is a 17% EDTA (disodium salt of ethylenediaminetetraacetic acid dihydrate) chelating agent. Available in thin and thick viscosities; thick formula utilizes a polyethylene glycol carrier. Used by dentists during endodontic procedures to facilitate root canal enlargement. Applied directly to the canal opening or to the endodontic file. Acts by chemically chelating calcium ions from dentin, softening the canal walls to assist mechanical filing and debridement. Product aids in clearing root canals that resist mechanical enlargement.
Clinical Evidence
No clinical data. Safety and effectiveness are supported by literature (Accepted Dental Therapeutics, Council on Dental Therapeutics of the American Dental Association) confirming the mechanism of action of EDTA in chelating calcium and aiding root canal preparation.
Technological Characteristics
Active ingredient: 17% Disodium salt of ethylenediaminetetraacetic acid dihydrate (EDTA). Base: Buffered, water-soluble. Carrier: Polyethylene glycol (thick formula). Form factor: Liquid/gel in two viscosities. Principle: Chemical chelation of calcium ions.
Indications for Use
Indicated for use by dentists as a chelating agent to aid in debriding and clearing root canals during endodontic procedures by chelating calcium from dentin.
Regulatory Classification
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.
Predicate Devices
- Ultradent File-Eze (K934415)
- Premier RC Prep
- Roth REDTA Chelating Agent
- Union Broach Endodilator N-O (MoycoEDTA)
- Pulpdent Endo-Prep (K896663)
- Pulpdent EDTA Preparations (K932791)
Related Devices
- K060335 — FILE-EZE · Ultradent Products, Inc. · Feb 24, 2006
- K072555 — EDTA PLUS · Essential Dental Systems, Inc. · Dec 13, 2007
- K032627 — ULTRADENT CITRIC ACID 10% SOLUTION · Ultradent Products, Inc. · Nov 12, 2003
- K153528 — PacEndo EDTA · Pac-Dent International, Inc. · Feb 1, 2016
- K082470 — SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA · Inter-Med, Inc. · Apr 3, 2009
Submission Summary (Full Text)
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K961089 14
# 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
FAX: (617) 926-6262 |
| --- | --- |
**DEVICE NAME:** PULPDENT Endo-Prep II
**PREDICATE DEVICES:**
- Ultradent File-Eze
- Premier RC Prep
- Roth REDTA Chelating Agent
- Union Broach Endodilator N-O
**DESCRIPTION AND INTENDED USE:** PULPDENT Endo-Prep II is a 17% EDTA 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 opening or to the file.
**COMPARISON WITH PREDICATE PRODUCTS:** PULPDENT Endo-Prep II is substantially equivalent in composition and intended use as the predicate products. Please see Exhibit 5 for the entire comparison.
**SAFETY AND EFFECTIVENESS:** According to *Accepted Dental Therapeutics*, 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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5
# EXHIBIT 5
## COMPARISON TABLE OF *PULPDENT ENDO-PREP II* AND PREDICATE PRODUCTS
| PARAMETER | *PULPDENT Endo-Prep II* | PREDICATE PRODUCTS | PRE-AMENDMENT OR 510(k) |
| --- | --- | --- | --- |
| Chelating agent | Disodium salt of ethylendiaminetetraacetic acid dihydrate (EDTA) | Ultradent *File-Eze*
Premier *RC Prep*
Roth *REDTA Chelating Agent*
Union Broach *MoycoEDTA*
*Pulpdent Endo-Prep*
*Pulpdent EDTA*
*Preparations* | K934415
Pre-amendment
Pre-amendment
K950365
K896663
K932791 |
| Buffered water soluble base | Thin and thick formula | Ultradent *File-Eze*
Premier *RC Prep*
Roth *REDTA Chelating Agent*
Union Broach *MoycoEDTA*
*Pulpdent Endo-Prep*
*Pulpdent EDTA*
*Preparations* | K934415
Pre-amendment
Pre-amendment
K950365
K896663
K932791 |
| Polyethylene glycol carrier | Thick formula | *Pulpdent Endo-Prep*
Pulpdent *EDTA*
*Preparations*
Ultradent *File-Eze*
Premier *RC Prep* | K896663
K932791
K934415
Pre-amendment |
| Intended use | Chelating agent for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin | Ultradent *File-Eze*
Premier *RC Prep*
Roth *REDTA Chelating Agent*
Union Broach *MoycoEDTA*
*Pulpdent Endo-Prep*
*Pulpdent EDTA*
*Preparations* | K934415
Pre-amendment
Pre-amendment
K950365
K896663
K932791 |
