HOWMEDICA BITE BLOCK
FDA 510(k) clearance K801911 · decided 1980-08-27
Clearance details
- K-number
- K801911
- Device name
- HOWMEDICA BITE BLOCK
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-11
- Decision date
- 1980-08-27
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- EGD
- Device class
- 1
- Regulation number
- 872.6890
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRACE EZE (K020009) | Udent, Inc. | 2002-02-11 |
| GLENROE ORTHO-SIL (K945535) | Glenroe Technologies | 1995-01-27 |
| ORTHO WAX (K924024) | Heraeus Kulzer, Inc. | 1992-11-17 |
| BURNOUT MATERIAL (K923586) | Dentsply Intl. | 1992-09-29 |
| SALIVA-STIM (K914892) | Orion Diagnostica, Inc. | 1992-09-02 |
| BITE RIM WAX (K922380) | Dentsply Intl. | 1992-06-16 |
| PALAVIT G (K914513) | Heraeus Kulzer, Inc. | 1992-03-19 |
| INTRAORAL DENTAL WAX (K910676) | Pemaco, Inc. | 1991-08-21 |
| PALAVIT GLC (K904928) | Kulzer, Inc. | 1991-06-06 |
| PEMACO 2000 INTRAORAL DENTAL WAX (K895562) | Pemaco, Inc. | 1989-11-06 |
| PEMACO 3000 INTRAORAL DENTAL WAX (K895561) | Pemaco, Inc. | 1989-11-06 |
| PEMACO BITE WAX SHEETS (K895563) | Pemaco, Inc. | 1989-11-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |