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 |
|---|---|---|---|
| Jul 12, 1994 | K940893 | A-DEC RADIUS 2122/2132 A-Dec, Inc. | EIA |
| Jun 10, 1994 | K941452 | ULTRACAM II Dental Vision Direct, Inc. | EIA |
| Jun 2, 1994 | K934436 | SBP DENTAL UNIT Northland Dental Engineering | EIA |
| May 16, 1994 | K934783 | KAVO INTRASEPT 905 Kavo America | EIA |
| Apr 29, 1994 | K940599 | DUAL AIR/WATER FILTER CARTRIDGE HANDLE KIT Q. C. Filter, Inc. | EIA |
| Apr 21, 1994 | K935325 | A-DEC CASCADE 3072 WALLMOUNT A-Dec, Inc. | EIA |
| Mar 31, 1994 | K933671 | ULTRACAM Dental Vision Direct, Inc. | EIA |
| Mar 7, 1994 | K932873 | SEAC MOBILE UNIT BY ASI MEDICAL Asi Medical, Inc. | EIA |
| Feb 22, 1994 | K930144 | THE SCITECH ONE-DAY FILTER Scitech Solutions, Inc. | EIA |
| Feb 4, 1994 | K934002 | PERIO/ENDO LENS New Image Industries, Inc. | EIA |
| Feb 1, 1994 | K934815 | AIR COMPRESSOR, MODEL PAC 6.7 Defiance Electronics, Inc. | EIA |
| Jan 21, 1994 | K931093 | QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE Dentalez Group | EIA |
| Jan 10, 1994 | K922652 | ACE BASIC DENTAL IMPLANT PACK I Ace Surgical Supply Co., Inc. | EIA |
| Jan 10, 1994 | K922651 | ACE DENTAL IMPLANT KIT Ace Surgical Supply Co., Inc. | EIA |
| Jan 10, 1994 | K922650 | ACE DENTAL IMPLANT CUSTOM SURGICAL PACK Ace Surgical Supply Co., Inc. | EIA |
| Jan 10, 1994 | K922649 | ACE BASIC DENTAL IMPLANT PACK II Ace Surgical Supply Co., Inc. | EIA |
| Jan 6, 1994 | K932878 | PRECISION INTRA-ORAL SCOPES Precise Optics | EIA |
| Jan 6, 1994 | K925798 | A-DEC 2545 DUO IC MICRO-CART A-Dec, Inc. | EIA |
| Jan 6, 1994 | K925797 | A-DEC 2544 DOCTORS IC MICRO-CART A-Dec, Inc. | EIA |
| Oct 20, 1993 | K933166 | A-DEC 2611 ASSISTANT'S CART A-Dec, Inc. | EIA |
| Oct 13, 1993 | K933167 | A-DEC 2912 DUO CART A-Dec, Inc. | EIA |
| Oct 12, 1993 | K933168 | A-DEC 3127 ASSISTANT'S WALLMOUNT A-Dec, Inc. | EIA |
| Oct 12, 1993 | K933165 | A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION) A-Dec, Inc. | EIA |
| Oct 12, 1993 | K933163 | A-DEC 2612 ASSISTANT'S CART A-Dec, Inc. | EIA |
| Oct 5, 1993 | K923354 | PORT OPII, PORT OPIII Mobile Dental Equipment Corp. | EIA |
| Sep 28, 1993 | K932824 | EVACUATOR, ORAL CAVITY Den-Tal-Ez Mfg Co., Inc. | EIA |
| Sep 10, 1993 | K922942 | PRO-SCOPE MODEL # PS-4000 Pro-Den Systems, Inc. | EIA |
| Aug 24, 1993 | K925967 | MEDCAM Medcam USA, Inc. | EIA |
| Jul 8, 1993 | K931204 | AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) Den-Tal-Ez Mfg Co., Inc. | EIA |
| May 27, 1993 | K922985 | CLEAN UP Bio-Probe, Inc. | EIA |
| Feb 12, 1993 | K925829 | WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM Waggoner Dental Mfg. | EIA |
| May 4, 1992 | K920710 | AIR MEDICA III Hinatawada Seimitsu Mfg. Co., Ltd. | EIA |
| Dec 27, 1991 | K915353 | MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP Matrix Medica, Inc. | EIA |
| Nov 13, 1991 | K914697 | MDT/CASTLE PURUS DENTAL UNIT Mdt Corp., Inc. | EIA |
| Nov 13, 1991 | K913464 | STOMAVISION (STV) Trophy Radiologie, FR | EIA |
| Jul 3, 1991 | K911594 | ORALCAM Charmac Group, Inc. | EIA |
| Jun 24, 1991 | K911506 | MODEL 2100 PORTABLE FIELD UNIT Dntl Corp. | EIA |
| Feb 20, 1991 | K905401 | ASEPTIMINI UNIT, ADU-10 Aseptico, Inc. | EIA |
| Jan 31, 1991 | K905011 | ORAL PHARYNGEAL CLEANSING DEVICE Concord/Portex | EIA |
| Jan 30, 1991 | K904948 | PM2002 CC AND PM2002 EC Planmeca USA, Inc., FI | EIA |
| Oct 24, 1990 | K903455 | A-DEC DECADE CUSPIDOR A-Dec, Inc. | EIA |
| Oct 24, 1990 | K903453 | A-DEC IC MICRO-CART A-Dec, Inc. | EIA |
| Oct 24, 1990 | K903452 | A-DEC IC CONTROL HEAD A-Dec, Inc. | EIA |
| Oct 24, 1990 | K903451 | A-DEC PAC I PORTABLE UNIT A-Dec, Inc. | EIA |
| Aug 15, 1990 | K901806 | SUCTION ORA-SWAB(R) BRUSH KIT Sage Products, Inc. | EIA |
| Jul 6, 1990 | K901672 | RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT Pelton & Crane Co. | EIA |
| Feb 12, 1990 | K896532 | DENTAL DELIVERY SYSTEM Dentech Corp. | EIA |
| Dec 26, 1989 | K895877 | RAMCLEAN DENTAL VACUUM LINE CLEANER Ramvac Corp. | EIA |
| Dec 26, 1989 | K895876 | RAMVAC DENTAL VACUUM SYSTEM Ramvac Corp. | EIA |
| Dec 21, 1989 | K894058 | ISODENT Eurodent, Inc., CA | EIA |
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