Block, Bite
Regulation 882.5070
0510(k)s in 12 months (28 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JXL
| Company | 510(k)s | Recalls |
|---|---|---|
| Scott All-Sports, Inc. | 2 | 0 |
| Somatics, Inc. | 2 | 0 |
| United States Endoscopy Group, Inc. | 2 | 0 |
| B&B Medical Technologies, Inc. | 1 | 0 |
| Brimms, Inc. | 1 | 0 |
| Cherry Plastics, Inc. | 1 | 0 |
| Dupaco, Inc. | 1 | 0 |
| Dyna-Med | 1 | 0 |
| Episafe Medical Devices, Ltd. | 1 | 0 |
| Ethox Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 22, 2023 | K221469 | PATI (Protector Against Tongue Injury) Neurovice, LLC | JXL |
| Jun 4, 2021 | K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium Mecta Corporation | JXL |
| Dec 22, 2017 | K172978 | SurgeoBite Surgovations, LLC | JXL |
| Jun 29, 2015 | K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm Dupaco, Inc. | JXL |
| Apr 27, 2005 | K050188 | EPIGUARD Episafe Medical Devices, Ltd. | JXL |
| Oct 25, 1999 | K992269 | VENTIL-A ORAL PROTECTOR Somatics, Inc. | JXL |
| May 17, 1996 | K960663 | UNIVERSAL BITE BLOCK B&B Medical Technologies, Inc. | JXL |
| Jan 25, 1996 | K954352 | BITE BLOCK United States Endoscopy Group, Inc. | JXL |
| Apr 5, 1995 | K941856 | PREMIER PROMAX BITE GUARD Premier Dental Products Co. | JXL |
| Apr 23, 1993 | K924333 | THE DAVIS DISPOSABLE PROTECTIVE SPLINT Ora-Gard, Inc. | JXL |
| Apr 6, 1993 | K924304 | BITE BLOCK United States Endoscopy Group, Inc. | JXL |
| Dec 9, 1992 | K921946 | TUM-E-VAC BITE BLOCK Ethox Corp. | JXL |
| Jun 28, 1990 | K901563 | MOUTHPIECE BREATHING Scott All-Sports, Inc. | JXL |
| Dec 14, 1989 | K896745 | JAW BLOCKER Plastic Engineered Products Co. | JXL |
| Feb 17, 1989 | K890567 | BITE BLOCK #59430 Medi-Source, Inc. | JXL |
| Oct 12, 1988 | K883416 | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) Scott All-Sports, Inc. | JXL |
| Feb 19, 1987 | K864962 | OBERTO MOUTH PROP Medovations, Inc. | JXL |
| Nov 3, 1986 | K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) Somatics, Inc. | JXL |
| Jun 5, 1986 | K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) Hi Chem, Inc. | JXL |
| Sep 11, 1984 | K842788 | DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE Brimms, Inc. | JXL |
| Apr 5, 1984 | K840789 | BITESTICK BLOCK Cherry Plastics, Inc. | JXL |
| Feb 7, 1983 | K830090 | DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR Hudson Oxygen Therapy Sales Co. | JXL |
| Aug 3, 1982 | K822018 | JACKSON BITE BLOCKS Kelleher Corp. | JXL |
| Nov 12, 1980 | K802696 | DENTAL MOUTH PROP. Trident Dental, Inc. | JXL |
| Feb 28, 1980 | K800369 | TRI PAC MOUTH PROP Oxequip Health Ind. | JXL |
| Nov 13, 1979 | K792157 | DENTAL MOUTHPROP (BITE BLOCK) Mission Dental, Inc. | JXL |
| Jan 31, 1977 | K770090 | BLACHLY BITE BLOK & CHEEK FILLER P.H. Blachly, M.D. | JXL |
| Jul 26, 1976 | K760258 | BITE STICK, DYNA Dyna-Med | JXL |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.