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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 1989 | K894061 | STUDIO UNO Eurodent, Inc., CA | EIA |
| Oct 13, 1989 | K894759 | ALLPAC(TM) MATERIAL Barrier Concepts, Inc. | EIA |
| Aug 7, 1989 | K893219 | MATRX DENTAL UNIT Matrix Medica, Inc. | EIA |
| May 24, 1989 | K891006 | QUICK-TIP (DENTAL OPERATORY UNIT) Bernard S Esrock | EIA |
| Mar 17, 1989 | K884219 | BRACKET TABLE ARM COVER Steri-Shield Products, Inc. | EIA |
| Mar 16, 1989 | K885299 | SANI-SLEEVE DRAPE FOR DENTAL USE Nieusma R & D, Inc. | EIA |
| Dec 8, 1988 | K882526 | DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR. Aseptico, Inc. | EIA |
| Dec 7, 1988 | K883904 | APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR Apollo Dental Products, Inc. | EIA |
| Oct 14, 1988 | K883775 | PORTABLE II DENTAL DELIVERY SYSTEM Dntl Corp. | EIA |
| Aug 12, 1988 | K882810 | EASY-OP, PORTABLE DENTAL CART Wy'East Medical Corp. | EIA |
| Oct 17, 1986 | K861601 | DP32 HAND HELD DENTAL PROPHYLAXIS UNIT Stewart J. Lustgarten | EIA |
| Oct 1, 1986 | K863021 | CM-II, CM-I WATER UNIT Sds Dental, Inc. | EIA |
| Sep 26, 1986 | K863010 | EUROCART SR-4, EUROCART M-IV, ISOCART III Sds Dental, Inc. | EIA |
| Sep 25, 1986 | K863023 | CABINET II AUXILIARY UNIT Sds Dental, Inc. | EIA |
| Mar 14, 1986 | K854643 | SOLAR Alpine Dental Equipment Co. | EIA |
| Mar 14, 1986 | K854642 | SOLAR CART Alpine Dental Equipment Co. | EIA |
| Mar 10, 1986 | K854641 | SOLAR F Alpine Dental Equipment Co. | EIA |
| Oct 24, 1985 | K852816 | FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10 Apollo Dental Products, Inc. | EIA |
| Jul 31, 1985 | K852524 | SATALEC SERVOTORQUE S2 SX2 Spelna, Inc. | EIA |
| Jul 31, 1985 | K851136 | TROPHY COMPACT - DENTAL UNIT Trophy Radiologie, FR | EIA |
| Sep 12, 1984 | K842357 | PM 2000 DENTAL UNIT Planmeca USA, Inc. | EIA |
| Oct 19, 1983 | K832673 | SATELEC PROPHY UNIT PU-2000 Spelna, Inc. | EIA |
| Dec 3, 1982 | K823230 | STERILE WATER SYSTEM Syntex Dental Products, Inc. | EIA |
| Nov 22, 1982 | K823180 | SA-21 DENTAL UNIT Ritter Co. | EIA |
| Nov 17, 1982 | K823133 | AIR FLOW I Healthco, Inc. | EIA |
| Nov 24, 1981 | K813106 | PORT-OP Portec, Inc. | EIA |
| Sep 9, 1980 | K801975 | LITTLE GIANT I & II HANDPIECE CONTROL Silverman'S | EIA |
| Aug 4, 1980 | K801685 | SPACELINE DENTAL CHAIR-UNIT Pacific Dental Corp. | EIA |
| Jul 14, 1980 | K801534 | LARES AIR PRESSURE GAUGE Lares Manufacturing Co., Inc. | EIA |
| Mar 17, 1980 | K800395 | ARISTOSURG 250 Halmon-Locren, Inc. | EIA |
| Feb 26, 1979 | K790112 | MOBILE UNITS, I,II,III,IV Dentsply Intl. | EIA |
| Dec 28, 1978 | K781882 | MODULAT DENTAL SYSTEMS Vacudent Sales Corp. | EIA |
| Aug 14, 1978 | K781114 | ULTRAMATE 990 Litton Dental Products | EIA |
| Oct 20, 1977 | K771890 | PERCEPTION SERIES DELIVERY SYS. Chayes Virginia, Inc. | EIA |
| Jul 15, 1977 | K771252 | CB600, TURBINE CONTROL BOL Litton Dental Products | EIA |
| Jul 15, 1977 | K771251 | HU:500, HYGIENASSIST Litton Dental Products | EIA |
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