510(k) K060347
- Device
- B&L L-BETA, MODEL WL-B1
- Applicant
- B&L Biotech Co., Ltd.
- 510(k) number
- K060347
- Product code
- EKR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-05
- Date received
- 2006-02-10
- Regulation
- 872.4565
- Classification name
- Plugger, Root Canal, Endodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL KAMM
- Address
- P.O. Box 7007 Deer Field IL US 60015 60015
FDA Registration Numbers#
- 3013552516
- 3012312751
- 9610612
- 8010704
- 3010442693
- 3013538161
- 3011215096
- 3027615
- 1419982
- 3005809810
- 2086043
- 8010159
- 3036795921
- 9680913
- 3005067367
- 3009968482
- 3007064566
- 3016075921
- 3017604
- 3004569445
- 3004992978
- 3012354669
- 3001644167
- 3002808270
- 3008770655
- 8030343
- 3007791573
- 1422507
- 2246990
- 3004417597
- 8030938
- 5906
- 1215305
- 3009171220
- 3010055973
- 2511556
- 8031010
- 3014937043
- 2024980
- 8010468
- 3038718579
- 9615399
- 3006621310
- 3001146947
- 3008249935
- 3011300255
- 8030607
- 1416605
- 8040881
- 3012101632
- 3005621335
- 3006444232
- 3005581016
- 3007301326
- 2520265
- 3010288346
- 9611367
- 3030644259
- 3005440795
- 3015526995
- 3008808049
- 8040278
- 2320721
- 9680864
- 1926681
- 8020994
- 1032227
- 3004425647
- 9680735
- 3008370577
- 3003418325
- 1836161
- 3017352116
- 1057946
- 3013946322
- 2521453
- 3009340886
- 3009130085
- 3012101664
Source Documents#
Other 510(k) Records For Product Code EKR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | Young O/S, LLC | 2004-12-01 |
| K031664 | ELEMENTS OBTURATION UNIT | Sybron Endo/Analytic | 2004-04-28 |
| K860569 | ENDODONTIC ROOT CANAL PLUGGER | Dentsply Intl. | 1986-03-26 |
| K831748 | ENDODONTIC ROOT CANAL PLUGGER FINGER- | Union Branch | 1983-07-12 |
| K791019 | MCSPADDEN CONDENSOR | Techdent, Inc. | 1979-08-03 |