Invasive Accessories AND Instruments

BROKEN SCREW EXTRACTOR KIT is a system that allow to remove broken thread into a fixture when it is not cemented or damaged attempting to remove it in other way.

Registry build 21.09.26
20manufacturers in China registered for this device type
62catalogue 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 Invasive Accessories AND Instruments
Listed by Rhein 83 SRL, Italy
FDA product code DZA
Device type Drill, Dental, Intraoral
Device class Class 1
Regulation 21 CFR 872.4130
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-07-08
Record revised 2024-06-19 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Distribution end date 2021-07-29

Catalogue Numbers

Catalogue numbers for Invasive Accessories AND Instruments
Catalogue number Size Status
ESTRATTORE IMP. CERTAIN 3i In distribution
ESTRATTORE IMP. NobelActive NP ø 3,5 In distribution
ESTRATTORE x IMP. Prima Connex WD ø 5 In distribution
ESTRATTORE IMP. ASTRA ø 4,5-5 Lilla In distribution
ESTRATTORE IMP. SKY ø 3,5-4-4,5 In distribution
CLAW REAMER BUR 1 u. In distribution
ESTRATTORE IMP. LEGACY ø 3 In distribution
ESTRATTORE IMP. NobelActive RP ø 4,3 In distribution
ESTRATTORE IMP. ASTRA ø 3,5-4 Acqua In distribution
EXTRACTOR IMP. BIO HORIZON E/E ø 5 In distribution
Extractor Kit X TRI Matrix® P45 In distribution
ESTRATTORE IMP. BONE LEVEL RC ø 4,1-4,8 In distribution
ESTRATTORE IMP. CERTAIN 3i ø 3,25 In distribution
ESTRATTORE IMP. STRAUMANN R/N In distribution
ESTRATTORE IMP. Prima Connex RD ø 4,1 In distribution
ESTRATTORE IMP. REPLACE Select ø 3,5 In distribution
CLAW REAMER BUR 1 u. In distribution
ESTRATTORE IMP. STRAUMANN WN In distribution
ESTR/CAPP. c/st. INSERITORE STRATEGY UDI In distribution
ESTRATTORE IMP. DRIVE CM (NEODENT) In distribution
ESTRATTORE IMP. STERI OSS HL ø 5 In distribution
ESTRATTORE IMP. SPLINE ø 3,25 In distribution
ESTRATTORE x IMP. ReplaceSelect ø 5 In distribution
EXTRACTOR IMP. ANYRIDGE In distribution
ESTRATTORE IMP. SCREW VENT ø 5,7 In distribution
MOOSER BUR FOR PIVOTS mms.7-9-10 mm In distribution
SPECIAL REVERSE CUTTING BUR 1 u. In distribution
EXTRACTOR KIT x ZIMMER TSV ø 3,5–4,5 In distribution
ESTRATTORE IMP. NEOSS ø 3,5-4-4,5-5-5,5 In distribution
ESTRATTORE IMP. BONE LEVEL NC ø 3,3 In distribution
Extractor Kit X TRI Matrix® P37 In distribution
SPECIAL BUR In distribution
ESTRATTORE-INSERITORE OBM con UDI In distribution
ESTRATTORE IMP. REPLACE Select ø 4,3 In distribution
BROKEN SCREW EXT.KIT ZIMMER ø 3,75 – 4,5 In distribution
SPECIAL REVERSE CUTTING BUR Withdrawn
CLAW REAMER BUR 1 u. Withdrawn
ESTRATTORE IMP. SCREW VENT ø 5,7 Withdrawn
ESTRATTORE x IMP. Prima Connex WD ø 5 Withdrawn
ESTRATTORE IMP. ANYRIDGE Withdrawn
ESTRATTORE IMP. ASTRA ø 4 Withdrawn
ESTRATTORE IMP. STRAUMANN R/N Withdrawn
BROKEN SCREW EXT.KIT ZIMMER ø 3,75 – 4,5 Withdrawn
ESTRATTORE IMP. BONE LEVEL NC ø 3,3 Withdrawn
ESTRATTORE IMP. Prima Connex RD ø 4,1 Withdrawn
ESTRATTORE IMP. ASTRA ø 4,5-5 Lilla Withdrawn
ESTRATTORE IMP. REPLACE Select ø 4,3 Withdrawn
SPECIAL BUR Withdrawn
CLAW REAMER BUR 1 u. Withdrawn
ESTRATTORE IMP. SKY ø 3,5-4-4,5 Withdrawn
ESTRATTORE IMP. ASTRA ø 3,5-4 Acqua Withdrawn
ESTRATTORE IMP. NobelActive NP ø 3,5 Withdrawn
BROKEN SCREW EXTRACTOR KIT Withdrawn
ESTRATTORE IMP. BRANEMARK E/E RP Withdrawn
EXTRACTOR KIT x ZIMMER TSV ø 3,5–4,5 Withdrawn
MOOSER BUR FOR PIVOTS mms.7-9-10 mm Withdrawn
ESTRATTORE IMP. BIO HORIZON E/E ø 5 Withdrawn
ESTRATTORE IMP. CERTAIN 3i Withdrawn
ESTRATTORE IMP. REPLACE Select ø 3,5 Withdrawn
ESTRATTORE IMP. LEGACY ø 3 Withdrawn
ESTRATTORE IMP. BIO HORIZON ø 3 Withdrawn
ESTRATTORE IMP. CERTAIN 3i ø 3,25 Withdrawn

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