Lava™ Plus
3M™ ESPE™ Lava™ Plus High Translucency Zirconia Mill Blanks – Multi XL, 6/Box, 69202 DM DI = 04035077019170
33manufacturers in China registered for this device type
106catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (10), Hunan (6), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BMF Tech (Zhuhai) Inc. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Jiangxi Rekonova Dental Materials Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 1 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Powder, Porcelain
Record
| Listed by | 3M Deutschland GmbH, Germany |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-12-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2018-04-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 69266 | In distribution | ||
| 69178 | In distribution | ||
| 69202 | 6 | In distribution | |
| 69264 | In distribution | ||
| 69207 | In distribution | ||
| 69206 | In distribution | ||
| 69209 | In distribution | ||
| 69271 | In distribution | ||
| 69391 | In distribution | ||
| 69267 | In distribution | ||
| 69260 | In distribution | ||
| 69216 | In distribution | ||
| 69178 | In distribution | ||
| 69219 | In distribution | ||
| 69205 | In distribution | ||
| 69392 | In distribution | ||
| 69204 | In distribution | ||
| 69273 | In distribution | ||
| 69179 | In distribution | ||
| 69273 | In distribution | ||
| 69204 | In distribution | ||
| 69201 | 12 | In distribution | |
| 69212 | In distribution | ||
| 69224 | In distribution | ||
| 69176 | In distribution | ||
| 69226 | In distribution | ||
| 69210 | In distribution | ||
| 69228 | In distribution | ||
| 69271 | In distribution | ||
| 69177 | In distribution | ||
| 69202 | 6 | In distribution | |
| 69215 | In distribution | ||
| 69181 | In distribution | ||
| 69220 | In distribution | ||
| 69180 | In distribution | ||
| 69209 | In distribution | ||
| 69221 | 12 | In distribution | |
| 69181 | In distribution | ||
| 69214 | In distribution | ||
| 69265 | In distribution | ||
| 69216 | In distribution | ||
| 69214 | In distribution | ||
| 69217 | In distribution | ||
| 69226 | In distribution | ||
| 69213 | In distribution | ||
| 69262 | In distribution | ||
| 69229 | In distribution | ||
| 69217 | In distribution | ||
| 69205 | In distribution | ||
| 69389 | In distribution | ||
| 69211 | In distribution | ||
| 69350 | In distribution | ||
| 69265 | In distribution | ||
| 69219 | In distribution | ||
| 69398 | In distribution | ||
| 69278 | In distribution | ||
| 69263 | In distribution | ||
| 69272 | In distribution | ||
| 69396 | In distribution | ||
| 69350 | In distribution | ||
| 69221 | 12 | In distribution | |
| 69224 | In distribution | ||
| 69208 | In distribution | ||
| 69264 | In distribution | ||
| 69179 | In distribution | ||
| 69229 | In distribution | ||
| 69222 | 6 | In distribution | |
| 69203 | In distribution | ||
| 69228 | In distribution | ||
| 69207 | In distribution | ||
| 69260 | In distribution | ||
| 69177 | In distribution | ||
| 69272 | In distribution | ||
| 69222 | 6 | In distribution | |
| 69390 | In distribution | ||
| 69262 | In distribution | ||
| 69399 | In distribution | ||
| 69210 | In distribution | ||
| 69227 | In distribution | ||
| 69215 | In distribution | ||
| 69176 | In distribution | ||
| 69220 | In distribution | ||
| 69180 | In distribution | ||
| 69266 | In distribution | ||
| 69218 | In distribution | ||
| 69261 | In distribution | ||
| 69263 | In distribution | ||
| 69394 | In distribution | ||
| 69213 | In distribution | ||
| 69208 | In distribution | ||
| 69395 | In distribution | ||
| 69261 | In distribution | ||
| 69206 | In distribution | ||
| 69218 | In distribution | ||
| 69201 | 12 | In distribution | |
| 69388 | In distribution | ||
| 69393 | In distribution | ||
| 69212 | In distribution | ||
| 69203 | In distribution | ||
| 69211 | In distribution | ||
| 69227 | In distribution | ||
| 69267 | In distribution | ||
| 69397 | In distribution | ||
| 69276 | Withdrawn | ||
| 69274 | Withdrawn | ||
| 69275 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bloomden | Bloomden Bioceramics (Hunan) Co., Ltd. | 6,340 |
| Upcera Dental Zirconia Blank For Aesthetic Restoration | Liaoning Upcera Co., Ltd. | 4,367 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 4,310 |
| Luxen 5G | Dentalmax Co., Ltd. | 3,903 |
| GC Initial™ | GC America Inc. | 2,724 |
| Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | 2,035 |
| Multi M Series | Dmax Co., Ltd. | 1,854 |
| Zirconia Dental Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 1,828 |
| Amber® Mill Q | Hass Corp. | 1,602 |
| Upcera Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 1,498 |
| BruxZir | Prismatik Dentalcraft, Inc. | 1,295 |
| ceraMotion® | Dentaurum GmbH & Co. KG | 1,062 |
Showing 12 of 10,017. All products under Powder, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161922 | 2016-09-01 |
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.