Unit, Operative Dental
Regulation 872.6640
2510(k)s in 12 months (286 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in EIA
| Company | 510(k)s | Recalls |
|---|---|---|
| A-Dec, Inc. | 25 | 0 |
| Pelton & Crane | 5 | 1 |
| Planmeca Oy | 6 | 0 |
| Aseptico, Inc. | 5 | 0 |
| Ace Surgical Supply Co., Inc. | 4 | 0 |
| Air Techniques, Inc. | 4 | 0 |
| Asi Medical, Inc. | 3 | 1 |
| Scitech Solutions, Inc. | 4 | 0 |
| Sds Dental, Inc. | 4 | 0 |
| Sirona Dental Systems GmbH | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2016 | Danville Materials, Inc. Perioscopy Sheath: Part number: 1008;
The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video Terminated |
EIA | K982480 |
| May 9, 2014 | William C. Domb, D.M.D., A Professional Corporation Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12
The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to Terminated |
EIA | None listed |
| Dec 19, 2013 | ASI Medical, Inc. SEAC Advanced Dental System, Model A591561
The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed ope Terminated |
EIA | K974487 |
| Mar 6, 2012 | Pelton & Crane Company Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273
Product Usage:
The intended use of the dental operative unit is for supplying pow Terminated |
EIA | K946187 |
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