510(k) K961089

Device: PULPDENT ENDOPREP II
Applicant: PULPDENT CORP.
510(k) number: K961089
Product code: EKL
Decision: Substantially Equivalent (SESE)
Decision date: 1996-04-23
Date received: 1996-03-19
Regulation: 872.3840
Classification name: Point, Silver, Endodontic
Medical specialty: Dental
Review panel: Dental
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KENNETH J BERK
Address: 80 Oakland St. Watertown MA US 02472 02472

FDA Registration Numbers#

3014334038
3021023132
3012494290
3038718579
1215305
2320721
3003418325
1836161
8030607
3001644167
2183301
3009171220

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00858395006097	Sonendo 17% EDTA	SONENDO, INC.	2017-02-08

Other 510(k) Records For Product Code EKL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K992582	PACIFIC IMPLANT TITANIUM ENDODONTIC POINT	Pacific Implant, Inc.	1999-10-21
K822568	EAR PROBES	Kelleher Corp.	1982-09-14

Legacy Summary#

summary

FDA Review#

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