Bioplate®

Drill Bit, 1.5mm diam., 4.5mm - Large

Registry build 21.09.26
20manufacturers in China registered for this device type
94catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (6), Jiangsu (5), Anhui (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZA
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
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
TF NEW Material SCI AND TEC Co., Ltd. Huainan Anhui Manufacturer 51
Hefei Mlush Sanitary Products Co., Ltd. Hefei Anhui Manufacturer 48
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
CDM Center OF Excellence Ltd. Beijing Beijing Manufacturer 29
Henan Lusterdent Medical Instrument Co., Ltd. Zhengzhou Henan Manufacturer 15
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14

Showing 12 of 20. All 20 manufacturers in China registered for Drill, Dental, Intraoral

Record

Regulatory record for Bioplate®
Listed by Bioplate, Inc., United States
FDA product code DZA
Device type Drill, Dental, Intraoral
Device class Class 1
Regulation 21 CFR 872.4130
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-10-23
Record revised 2024-06-19 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Sizes Length 42 to 86 mm; length 45.7 in

Catalogue Numbers

Catalogue numbers for Bioplate®
Catalogue number Size Status
DBZ3-04 Length 52 mm In distribution
DBP4-10 Length 50 mm In distribution
81-3411 Length 85 mm In distribution
81-3065 Length 45.7 mm In distribution
81-2019 Length 50 mm In distribution
81-3073 Length 50 mm In distribution
81-3068 Length 73.4 mm In distribution
81-3427 Length 78 mm In distribution
DBP4-06 Length 50 mm In distribution
81-3487 Length 42 mm In distribution
DBZ4-06 Length 52 mm In distribution
81-3485 Length 42 mm In distribution
81-3072 Length 73.4 mm In distribution
81-3376 Length 52 mm In distribution
81-3044 Length 50 mm In distribution
DBP4-06-SALE Length 50 mm In distribution
DBP8-14 Length 50 mm In distribution
81-3066 Length 45.7 mm In distribution
81-3075 Length 50 mm In distribution
DBP8-06-SALE Length 50 mm In distribution
81-3077 Length 72 mm In distribution
DBP8-10-SALE Length 50 mm In distribution
81-3081 Length 72 mm In distribution
81-3429 Length 78 mm In distribution
81-3079 Length 72 mm In distribution
81-3377 Length 52 mm In distribution
81-3086 Length 82 mm In distribution
81-3078 Length 72 mm In distribution
DBP8-06 Length 50 mm In distribution
DBP2-20-SALE Length 50 mm In distribution
81-3423 Length 80 mm In distribution
DBP8-04 Length 50 mm In distribution
81-3070 Length 73.4 mm In distribution
81-3484 Length 62 mm In distribution
DBZ2-04 Length 52 mm In distribution
81-3061 Length 45.7 in In distribution
81-3084 Length 82 mm In distribution
81-3414 Length 86 mm In distribution
DBP2-06 Length 50 mm In distribution
DBZ4-04 Length 52 mm In distribution
81-3428 Length 78 mm In distribution
81-3067 Length 73.4 mm In distribution
81-3412 Length 85 mm In distribution
DBZ2-04-SALE Length 52 mm In distribution
81-3083 Length 82 mm In distribution
DBP2-10 Length 50 mm In distribution
81-3490 Length 42 mm In distribution
81-3416 Length 86 mm In distribution
81-2033 Length 50 mm In distribution
81-3483 Length 62 mm In distribution
DBZ3-06 Length 52 mm In distribution
81-3410 Length 85 mm In distribution
DBP2-04 Length 50 mm In distribution
81-3425 Length 80 mm In distribution
DBP4-20 Length 50 mm In distribution
81-3420 Length 72 mm In distribution
DBP4-20-SALE Length 50 mm In distribution
81-3422 Length 72 mm In distribution
DBP4-04 Length 50 mm In distribution
81-3417 Length 85 mm In distribution
81-3082 Length 72 mm In distribution
81-3481 Length 62 mm In distribution
81-3482 Length 62 mm In distribution
81-3426 Length 78 mm In distribution
81-3418 Length 72 mm In distribution
81-3080 Length 72 mm In distribution
DBP8-04-SALE Length 50 mm In distribution
81-3413 Length 85 mm In distribution
81-3064 Length 45.7 mm In distribution
81-2020 Length 50 mm In distribution
DBP2-06-SALE Length 50 mm In distribution
81-3424 Length 80 mm In distribution
81-3421 Length 72 mm In distribution
81-3486 Length 42 mm In distribution
81-3489 Length 62 mm In distribution
81-3085 Length 82 mm In distribution
DBZ2-06 Length 52 mm In distribution
81-3063 Length 45.7 in In distribution
DBP2-14-SALE Length 50 mm In distribution
DBP2-04-SALE Length 50 mm In distribution
81-3069 Length 73.4 mm In distribution
81-3071 Length 73.4 mm In distribution
81-3076 Length 50 mm In distribution
81-3045 Length 50 mm In distribution
81-3062 Length 45.7 in In distribution
81-3480 Length 62 mm In distribution
DBP2-14 Length 50 mm In distribution
K248-50 In distribution
81-3415 Length 86 mm In distribution
81-3419 Length 72 mm In distribution
DBP4-04-SALE Length 50 mm In distribution
81-3074 Length 50 mm In distribution
81-2018 Length 50 mm In distribution
DBP8-10 Length 50 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Neobiotech Implant System Neobiotech Co., Ltd. 685
Jota Jota AG 307
OneGuide Taper Drill Osstem Implant Co., Ltd. 291
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 286
122 Taper Drill Osstem Implant Co., Ltd. 285
Taper Drill Osstem Implant Co., Ltd. 279
Edenta Edenta Etablissement 275
Bone Compaction Drill Osstem Implant Co., Ltd. 200
Dental Surgical Drill Cowellmedi Co., Ltd. 195
Twist Drill Osstem Implant Co., Ltd. 169
Bondent United Dental Changzhou 166
Ritter Implants Dental System Ritter Implants GmbH & Co. KG 156

Showing 12 of 875. All products under Drill, Dental, Intraoral

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer