ENGLER 25K SERIES ULTRASONIC INSERTS
ENGLER ENGINEERING CORP.
ENGLER ENGINEERING CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1036336 | 1036336 | ENGLER ENGINEERING CORP. | 1 | N | 2020-04-25 | 1099 E 47th St HIALEAH FL US 33013 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 28584 | 1397792203 | K832443 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | ELC | 1983-09-12 |
| 28584 | 1503217210 | K820162 | TEC-SON II | ELC | 1982-02-24 |
| 28584 | 1212259149 | K811396 | SONUS V | ELC | 1981-06-26 |
| 28584 | 1281911030 | K122748 | ENGLER 25K SERIES ULTRASONIC INSERTS | ELC | 2013-06-11 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| ELC | 4 | 2013-06-11 |
PMN#
GUDID#
Sonus - Dental scaling tip - rounded point for Engler insert A47030
2021-05-04
Sonus - Dental scaling tip - fine point for use with the Engler A47030 Insert
2021-05-04
Sonus M4 - Dental scaling tip - broad spatula style to screw into Engler insert A47030
2021-05-04
Sonus Stack (Insert) - Sonus 18K magnetostrictive insert with threads for interchangeable tips for the Sonus V dental device
2021-05-04
Sonus Nose Cone - White plastic nose cone which slips over tip and provides means of tightening tip to insert. (For use with Sonus V device)
2021-05-04
SONUS V - Dental magnetostrictive scaler 18 K, with four (4) M series tips (2 - M1 and 2 M2 or M4) insert and nose cone.
2021-05-04
Engler 25K Series - Dental 25K magnetostrictive insert with pointed tip
2021-05-04
Engler 25K Series - Dental 25K magnetostrictive insert with broad spatula tip
2021-05-04
SONUS V SCALER - Dental magnorestrictive scaler with M series (133-120x) tips, Nose Cone and Insert
2018-07-16
Sonus M 2 Tip - Dental Scaling Tip - Fine Point
2018-07-16
Sonus M 3 Tip - Sonus Scaling Tip - Sickle
2018-07-16
Engler 25K Series S-4 - Dental 25K Insert with Spatula Tip
2018-07-09
Sonus Stack - Sonus 18K magnetorestrictive insert
2018-07-09
Sonus Nose Cone - White plastic nose cone for scaling handpiece
2018-07-09
Sonus M 1 Tip - Dental Scaling Tip - Standard point
2018-07-09
Sonus M 4 Tip - Dental Scaling Tip - Spatula
2018-07-09
Engler 25K Series S-1 - Dental 25 K insert with pointed tip
2018-07-09