CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
FDA 510(k) clearance K002693 · decided 2000-11-09
Clearance details
- K-number
- K002693
- Device name
- CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
- Applicant
- Cbs Intl. B.V.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-29
- Decision date
- 2000-11-09
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- EBL
- Device class
- 1
- Regulation number
- 872.3740
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Almere, NL
- 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 |
|---|---|---|
| DENTAURUM JACKET CROWN & ROOT POSTS (K952868) | Dentauraum, Inc. | 1995-07-19 |
| ROOT CANAL POST (K924376) | The Thera Group | 1993-11-22 |
| PROSTHETIC RESTORATION DEVICE (K895283) | Swiss Precision Mfg. Corp. | 1990-02-14 |
| PLASTIC TOOTH REINFORCEMENT KIT (K895758) | Nanzee Dental Products | 1989-12-20 |
| ELGILOY (K883074) | Dale T. Dupuis | 1988-08-09 |
| VIVADENT FILPIN (K863831) | Vivadent (Usa), Inc. | 1986-10-14 |
| SECURIPIN (K844457) | Hughes Int'L, Inc. | 1984-12-27 |
| MARKLEY THREADED WIRE (K830773) | Almore Intl., Inc. | 1983-04-28 |
| REINFORCING PIN (K822412) | Filhol | 1982-08-30 |
| SAFE-T-PINS RETENTIVE PIN SYSTEM (K760723) | Parkell, Inc. | 1976-10-21 |
Recalls involving this device
No recalls on record reference this clearance.