Hu-Friedy
Lg End BB18/Lg End PLGH1 Satin Steel Hdl
5manufacturers in China registered for this device type
196catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | EKJ |
| Device type | Burnisher, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-10-17 |
| Record revised | 2024-10-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BB42857 | In distribution | |
| TN5484 | In distribution | |
| TNPCCI | In distribution | |
| MAR-B3 | In distribution | |
| 3A0390 | In distribution | |
| SHAW4 | In distribution | |
| BBKOT2 | In distribution | |
| BB4063 | In distribution | |
| BB6260 | In distribution | |
| 3A0100 | In distribution | |
| BBKOT14 | In distribution | |
| BB4285 | In distribution | |
| BB56047 | In distribution | |
| BBROM | In distribution | |
| MAR-SB1 | In distribution | |
| BB2/29 | In distribution | |
| BB1290 | In distribution | |
| BBKOT12 | In distribution | |
| TNCIGMI3CH | In distribution | |
| BBKOT13 | In distribution | |
| BB27/298 | In distribution | |
| MAR-SB5 | In distribution | |
| TNBB21B | In distribution | |
| MARB7162 | In distribution | |
| CTNBB27/29 | In distribution | |
| 3A0150 | In distribution | |
| BB1294 | In distribution | |
| BB21B | In distribution | |
| BB27/297 | In distribution | |
| TNBB18 | In distribution | |
| MAR-SB4 | In distribution | |
| CTNTAM1 | In distribution | |
| BB7171 | In distribution | |
| 3A0175 | In distribution | |
| MAR-SB3 | In distribution | |
| 3A0235A | In distribution | |
| BB62606 | In distribution | |
| TNBBS/M | In distribution | |
| MBPFIAFR | In distribution | |
| CTNBBL2 | In distribution | |
| BB6615 | In distribution | |
| TNBBL3CH | In distribution | |
| 3A0295 | In distribution | |
| TN7187 | In distribution | |
| BB1300 | In distribution | |
| BBKOT5 | In distribution | |
| BB29/34 | In distribution | |
| BBKOT6 | In distribution | |
| MAR-B1 | In distribution | |
| BB2DE | In distribution | |
| BB1293 | In distribution | |
| TNBB27/29 | In distribution | |
| 3A0105 | In distribution | |
| BB5613 | In distribution | |
| BB27/296 | In distribution | |
| BB1303 | In distribution | |
| BB6802 | In distribution | |
| BBKOT26/27 | In distribution | |
| CTNFF3/4 | In distribution | |
| BBL3 | In distribution | |
| BBKOT3 | In distribution | |
| MBPFIAFL | In distribution | |
| CTNBB18 | In distribution | |
| 3A0075 | In distribution | |
| CTNPCCI | In distribution | |
| 3A0125 | In distribution | |
| BBUT1 | In distribution | |
| 3A0070 | In distribution | |
| MAR-B4 | In distribution | |
| TNCVKR1CH | In distribution | |
| TNTAM3 | In distribution | |
| BBKOT11 | In distribution | |
| CTNBB26/27S | In distribution | |
| CTNBB2/29 | In distribution | |
| BB6629 | In distribution | |
| BB2SE | In distribution | |
| BB6309 | In distribution | |
| BB21B8 | In distribution | |
| BB471/7373 | In distribution | |
| BB216 | In distribution | |
| CTNBBS/M | In distribution | |
| BB6698 | In distribution | |
| BB7007 | In distribution | |
| BBL2 | In distribution | |
| BB27/29 | In distribution | |
| BB7070 | In distribution | |
| MAR-B5 | In distribution | |
| CTNBBL3 | In distribution | |
| TNTAM1 | In distribution | |
| BB6802K8 | In distribution | |
| CTNBB21B | In distribution | |
| BB218 | In distribution | |
| BB29/PKT3M | In distribution | |
| BB18 | In distribution | |
| MBP-CB1 | In distribution | |
| BB21B7 | In distribution | |
| BB217 | In distribution | |
| BB26/27S6 | In distribution | |
| TNBBL2 | In distribution | |
| BBL36 | In distribution | |
| BBKOT4 | In distribution | |
| MAR-SB2 | In distribution | |
| TNBBL3 | In distribution | |
| 3A0145 | In distribution | |
| TNBB5408 | In distribution | |
| BB6565 | In distribution | |
| BB21B6 | In distribution | |
| 3A0280 | In distribution | |
| BBKOT1 | In distribution | |
| BB6000 | In distribution | |
| BB26/27S | In distribution | |
| TN6550CH | In distribution | |
| BBUT16 | In distribution | |
| 3A0060 | In distribution | |
| BB21 | In distribution | |
| BB1297 | In distribution | |
| BB186 | In distribution | |
| MAR-B2 | In distribution | |
| 3A0050 | In distribution | |
| BB31/277 | Withdrawn | |
| BB5265 | Withdrawn | |
| BB5229 | Withdrawn | |
| TNBB6569 | Withdrawn | |
| BB7091 | Withdrawn | |
| BB6614 | Withdrawn | |
| TN8128 | Withdrawn | |
| BB5627 | Withdrawn | |
| BB6802K | Withdrawn | |
| BB4291 | Withdrawn | |
| BB7008 | Withdrawn | |
| BB1006 | Withdrawn | |
| BB43626 | Withdrawn | |
| BB4498 | Withdrawn | |
| BB1871 | Withdrawn | |
| BB5464 | Withdrawn | |
| BB1442 | Withdrawn | |
| BB21B/CD6 | Withdrawn | |
| BB1440 | Withdrawn | |
| BB7093 | Withdrawn | |
| BB1307 | Withdrawn | |
| BB5615 | Withdrawn | |
| BB7177 | Withdrawn | |
| TNC6686 | Withdrawn | |
| BB6566 | Withdrawn | |
| BB1368 | Withdrawn | |
| BB5540 | Withdrawn | |
| TN7169 | Withdrawn | |
| BB5220 | Withdrawn | |
| BB7092 | Withdrawn | |
| BB5626 | Withdrawn | |
| TNCI6660 | Withdrawn | |
| BB7071K | Withdrawn | |
| BB7182 | Withdrawn | |
| BB5547 | Withdrawn | |
| TN7119 | Withdrawn | |
| BB1699 | Withdrawn | |
| TNC8107 | Withdrawn | |
| BB5406 | Withdrawn | |
| BB6588 | Withdrawn | |
| BB1401 | Withdrawn | |
| BBL65307 | Withdrawn | |
| BB4456 | Withdrawn | |
| BB55736 | Withdrawn | |
| BBROM71 | Withdrawn | |
| TN7129 | Withdrawn | |
| BB5323 | Withdrawn | |
| BB5614 | Withdrawn | |
| BB5225 | Withdrawn | |
| BB1295 | Withdrawn | |
| BB1375 | Withdrawn | |
| TN7117 | Withdrawn | |
| BB1301 | Withdrawn | |
| BB955MBASS | Withdrawn | |
| BB4082 | Withdrawn | |
| BB5538 | Withdrawn | |
| BB5138 | Withdrawn | |
| BB5396 | Withdrawn | |
| BB5431 | Withdrawn | |
| TN7112 | Withdrawn | |
| BB7126 | Withdrawn | |
| BB7164 | Withdrawn | |
| BB6601 | Withdrawn | |
| TNPCCICH | Withdrawn | |
| BB7005 | Withdrawn | |
| BB51386 | Withdrawn | |
| BB44566 | Withdrawn | |
| BB4362 | Withdrawn | |
| BB6690KB | Withdrawn | |
| NUB52 | Withdrawn | |
| BB6563 | Withdrawn | |
| TNBB7175 | Withdrawn | |
| TN7122 | Withdrawn | |
| BB1299 | Withdrawn | |
| BB5422 | Withdrawn | |
| BB1287 | Withdrawn | |
| BB5573 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 157 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 58 |
| Power Dental USA | Power Dental U.S.A. Inc. | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 24 |
| J & J Instruments Inc | J & J Instruments, LLC | 21 |
| Pomee | Pomee Corporation | 21 |
| Zoll-Dental | Zoll-Dental | 16 |
| PDT, Inc. | PDT, Inc. | 14 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 14 |
| Henry Schein | Henry Schein, Inc. | 7 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 5 |
| Burkhart Dental | Nordent Manufacturing Inc | 5 |
Showing 12 of 54. All products under Burnisher, Operative
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K912473 | 1991-07-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.