(35 days)
Not Found
No
The device is a chemical chelating agent, and the description focuses on its chemical properties and application method, with no mention of AI or ML.
No
The device is described as a chelating agent used for debriding and clearing the root canal. While it aids in a medical procedure, it is a chemical agent, not a device that itself provides a therapeutic effect through physical or mechanical means. Its function is to facilitate the filing process by chemical action (chelating calcium from dentin).
No
Explanation: The "Intended Use" and "Device Description" sections state that PULPDENT Endo-Prep II is a chelating agent used for debriding and clearing the root canal, aiding in the filing process. It is a treatment agent, not a diagnostic tool that identifies or screens for medical conditions.
No
The device description clearly states it is a 17% EDTA chelating agent, which is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "debriding and clearing the root canal during endodontic procedures." This is a procedure performed directly on a patient's tooth, not on a sample taken from the body.
- Mechanism of Action: The device works by chelating calcium from dentin within the root canal. This is a chemical action within the body (or on a part of the body).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not fit that description.
The device is a medical device used in a dental procedure, but it is not an in vitro diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K934415, K950365, K896663, K932791
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
ાધ
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."
1
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 |
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