B&L L-BETA, MODEL WL-B1
FDA 510(k) clearance K060347 · decided 2006-06-05
Clearance details
- K-number
- K060347
- Device name
- B&L L-BETA, MODEL WL-B1
- Applicant
- B&L Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-10
- Decision date
- 2006-06-05
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- EKR
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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| OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 (K042828) | Young O/S, LLC | 2004-12-01 |
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| ENDODONTIC ROOT CANAL PLUGGER (K860569) | Dentsply Intl. | 1986-03-26 |
| ENDODONTIC ROOT CANAL PLUGGER FINGER- (K831748) | Union Branch | 1983-07-12 |
| MCSPADDEN CONDENSOR (K791019) | Techdent, Inc. | 1979-08-03 |
Recalls involving this device
No recalls on record reference this clearance.