Biolight

Biolight ST Epoxy-Free Fiber Posts Intro KIT

Registry build 21.09.26
10manufacturers in China registered for this device type
37catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Jiangsu (2), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ELR
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
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Alwings Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 39
Henan Lusterdent Medical Instrument Co., Ltd. Zhengzhou Henan Manufacturer 15
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15
Shenzhen Forever Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9

Record

Regulatory record for Biolight
Listed by Synca Marketing, Canada
FDA product code ELR
Device type Post, Root Canal
Device class Class 1
Regulation 21 CFR 872.3810
Establishment Repacker / relabeller, Exporter
Premarket notification Exempt
Record published 2016-09-26
Record revised 2021-07-16 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Sizes Outer diameter 1 to 1.5 mm
Distribution end date 2021-07-26
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Biolight
Catalogue number Size Per pack Status
BST50 Outer Diameter 1.00mm 1.20mm 1.35mm 1.50mm In distribution
BDT12 2 10 In distribution
BST220 Outer Diameter 1.20 mm In distribution
BST120 Outer Diameter 1.20 mm 10 In distribution
BDT13 3 10 In distribution
BST100 Outer Diameter 1.00 mm 10 In distribution
BDT33 3 In distribution
BDT25 0.5 In distribution
BDT05 0.5 10 In distribution
BST200 Outer Diameter 1.0 mm In distribution
BDT40 Biolight dual post # 0.5 – 1 – 2 – 3 Biolight reamer # 0.5 – 1 – 2 -3 In distribution
BST135 Outer Diameter 1.35 mm 10 In distribution
BDT11 1 10 In distribution
BDT31 1 In distribution
BST150 Outer Diameter 1.50 mm 10 In distribution
BDT32 2 In distribution
BST250 Outer Diameter 1.50 mm In distribution
BST235 Outer Diameter 1.35 mm In distribution
BDT05 0.5 10 Withdrawn
BDT32 2 Withdrawn
BDT25 0.5 Withdrawn
BST100 Outer Diameter 1.00 mm 10 Withdrawn
BST135 Outer Diameter 1.35 mm 10 Withdrawn
BDT11 1 10 Withdrawn
BST220 Outer Diameter 1.20 mm Withdrawn
BDT33 3 Withdrawn
BDT25 0.5 Withdrawn
BST250 Outer Diameter 1.50 mm Withdrawn
BDT12 2 10 Withdrawn
BST50 Outer Diameter 1.00mm 1.20mm 1.35mm 1.50mm Withdrawn
BDT31 1 Withdrawn
BDT40 Biolight dual post # 0.5 – 1 -2-3. Biolight reamer # 0.5 – 1 – 2 – 3. Withdrawn
BST235 Outer Diameter 1.35 mm Withdrawn
BST200 Outer Diameter 1.0 mm Withdrawn
BDT13 3 10 Withdrawn
BST120 Outer Diameter 1.00 mm 10 Withdrawn
BST150 Outer Diameter 1.50 mm 10 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Henry Schein Henry Schein, Inc. 115
ParaPost XP Coltene/Whaledent Gmbh & Co. KG 111
Darby Dental Supply, LLC Darby Dental Supply, LLC 90
Hahnenkratt E. Hahnenkratt Gmbh 89
Surtex Dentatus AB 84
ParaPost Coltene/Whaledent Gmbh & Co. KG 46
Brasseler USA Peter Brasseler Holdings, LLC 44
Two Striper Abrasive Technology, LLC 43
Johnson-Promident Young Innovations Inc. 41
Flexi-Post Essential Dental Systems, Inc. 40
Integra® Miltex® Integra LifeSciences Production Corporation 37
Endodontic Posts Rhein 83 SRL 31

Showing 12 of 231. All products under Post, Root Canal

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