File, Pulp Canal, Endodontic
Regulation 872.4565
0510(k)s in 12 months (31 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in EKS
| Company | 510(k)s | Recalls |
|---|---|---|
| Union Broach, Div. Moyco Industries, Inc. | 4 | 0 |
| Miltex, Inc. | 2 | 0 |
| Ormco Corp. | 1 | 1 |
| Tycom Dental | 2 | 0 |
| United Dental Mfg., Inc. | 2 | 0 |
| A Company, Inc. | 1 | 0 |
| Angiosystems, Inc. | 1 | 0 |
| C & S Microinstruments , Ltd. | 1 | 0 |
| Coltene, Inc. | 1 | 0 |
| Dental Power, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2025 | US Endodontics, LLC Brasseler ESR Rotary/Reciprocating Endodontic File
Device SKU
AP120213PK
AP120253PK
AP120313PK
AP125213PK
AP125253PK
AP125313PK
AP135213PK
AP135253PK
AP135313PK
AP145213PK
AP145253PK
AP145313PK
AP1GP Open, Classified |
EKS | None listed |
| Feb 1, 2013 | Ormco/Sybronendo Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031.
An engine-driven rotary endodontic ins Terminated |
EKS | None listed |
| Mar 6, 2012 | Ormco Corporation K3 Engine File G-Pack,
Product: Endodontic Pulp Canal File, Part Number: 830-9925.
For use in root canal preparation. Terminated |
EKS | None listed |
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