Paltop

Fully Guided Drill for Pin Fixation Ø2mm L20mm

Registry build 21.09.26
20manufacturers in China registered for this device type
113catalogue 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 Paltop
Listed by Paltop Advanced Dental Solutions Ltd, Israel
FDA product code DZA
Device type Drill, Dental, Intraoral
Device class Class 1
Regulation 21 CFR 872.4130
Establishment Contract manufacturer, Specification developer, Manufacturer, Exporter
510(k) K131451
Record published 2021-12-14
Record revised 2024-03-25 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Sizes Length 3.25 to 5 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Paltop
Catalogue number Size Status
60-70056 In distribution
60-70036 In distribution
30-70306 In distribution
60-70048 2.0/1.5mm Long In distribution
30-70313 In distribution
60-70120 In distribution
60-70041 In distribution
60-70147 In distribution
30-70301 In distribution
60-70147 In distribution
60-70114 In distribution
30-70309 In distribution
60-70049 In distribution
30-70305 In distribution
60-70020 In distribution
60-70092 In distribution
30-70319 In distribution
60-70039 Length 4.2 mm In distribution
60-70053 3.8/3.2mm Short In distribution
60-70168 In distribution
30-70333 In distribution
30-70312 In distribution
60-70168 In distribution
30-70322 In distribution
60-70121 In distribution
60-70167 In distribution
60-70050 In distribution
60-70141 In distribution
60-70082 In distribution
30-70318 In distribution
60-70141 In distribution
60-70143 In distribution
30-70329 In distribution
60-70143 In distribution
60-70037 Length 3.75 mm In distribution
60-70020 In distribution
60-70054 In distribution
60-70051 3.2/2.4mm Short In distribution
30-70315 In distribution
30-70328 In distribution
60-70127 In distribution
60-70140 In distribution
30-70023 In distribution
30-70327 In distribution
30-70308 In distribution
30-70316 In distribution
60-70091 In distribution
60-70117 In distribution
60-70078 In distribution
60-70037 In distribution
60-70035 In distribution
60-70034 In distribution
60-70040 In distribution
30-70321 In distribution
60-70078 In distribution
60-70145 In distribution
30-70331 In distribution
60-70081 Osteotome For 3.25 Dia. Implant In distribution
30-70325 In distribution
60-70128 In distribution
60-70145 In distribution
30-70320 In distribution
60-70035 Length 3.25 mm In distribution
60-70121 In distribution
30-70326 In distribution
60-70059 In distribution
60-70083 In distribution
60-70098 In distribution
30-70314 In distribution
60-70123 In distribution
60-70048 In distribution
60-70144 In distribution
30-70302 In distribution
60-70080 In distribution
60-70084 In distribution
60-70052 3.2/2.4mm Long In distribution
60-70050 2.4/2.0mm Long In distribution
60-70077 In distribution
60-70123 In distribution
60-70167 In distribution
60-70081 In distribution
60-70054 3.8/3.2mm Long In distribution
60-70047 In distribution
30-70332 In distribution
60-70150 In distribution
60-70051 In distribution
60-70077 In distribution
60-70120 In distribution
60-70034 In distribution
60-70049 2.4/2.0mm Short In distribution
60-70144 In distribution
60-70090 In distribution
60-70083 Osteotome For 4.2 Dia. Implant In distribution
60-70140 In distribution
30-70304 In distribution
60-70058 In distribution
60-70084 Osteotome For 5.0 Dia. Implant In distribution
60-70038 In distribution
60-70031 In distribution
60-70036 In distribution
60-70047 2.0/1.5mm Short In distribution
60-70082 Osteotome For 3.75 Dia. Implant In distribution
60-70041 Length 5.0 mm In distribution
30-70310 In distribution
30-70307 In distribution
60-70098 In distribution
60-70057 In distribution
60-70038 In distribution
60-70040 In distribution
60-70052 In distribution
60-70039 In distribution
60-70053 In distribution
60-70118 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