# K961089: Pulpdent Endoprep II

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Apr 23, 1996 after 35 days
- Product code: EKL (Point, Silver, Endodontic)
- Device class: 1
- Regulation: 21 CFR 872.3840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896663 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950365: Moyco-Edta, Union Broach, Div. Moyco Industries, Inc. (1995) Summary page 2.
- K896663: Endo-Prep, Pulpdent Corp. (1990) Summary page 2.
- K932791: Pulpdent Edta Preparations, Pulpdent Corp. (1993) Summary page 2.
- (no number) Ultradent File-Eze: named in the summary without a submission number
- (no number) Premier RC Prep: named in the summary without a submission number
- (no number) Roth REDTA Chelating Agent: named in the summary without a submission number
- (no number) Union Broach Endodilator N-O: named in the summary without a submission number

## Indications for 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.

Source page: https://510kreport.com/device/K961089
Methodology: https://510kreport.com/methodology