CanalPro

Kit containing the following: (1) CanalPro Endo-Ice Green (1) HySolate Latex Dental Dam Black printed medium 152x152, 36 pcs (1) MicroMega K-Files B6 n008 L25 Sterile (1) MicroMega K-Files…

Registry build 21.09.26

Kit containing the following: (1) CanalPro Endo-Ice Green (1) HySolate Latex Dental Dam Black printed medium 152×152, 36 pcs (1) MicroMega K-Files B6 n008 L25 Sterile (1) MicroMega K-Files B6 n010 L25 Sterile (1) HyFlex EDM NiTi File Finishing Set, 25mm, 3 pcs (1) CanalPro NAOCL 6% 480 ML (1) Guttapercha points HyFlex EDM OGSF (1) HyFlex EDM Guttapercha Points Assortment, 60 pcs (1) Paper points HyFlex EDM OGSF 30/.04 (1) HyFlex Paper Points EDM Assortment, 100 pcs (1) Motor CanalPro X-Move (5) HyFlex EDM OGSF Sequence, 25mm, 4pcs (1) HyFlex EDM 40/.04 Finisher File, 25mm (1) Paper points HyFlex.04 #40 (1) Guttapercha points HyFlex EDM.04 #40 (5) B5 One RECI n25 6% L25 P. PACK Sterile (1) CanalPro EndoUltra Motor (1) CanalPro EDTA 480ML (1) CanalPro Side-Port Tips, 30ga, 100/bag (1) ROEKO GuttaFlow 2 Standard Set, 5 ml

2manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangxi (1), Hunan (1).

Chinese manufacturers registered for FDA product code EAT
Manufacturer City Province Registered as Device types
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17

Record

Regulatory record for CanalPro
Listed by Coltene/Whaledent Gmbh & Co. KG, Germany
FDA product code EAT
Device type Tester, Pulp
Device class Class 2
Regulation 21 CFR 872.1720
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2019-12-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature up to 120 °F

Catalogue Numbers

Catalogue numbers for CanalPro
Catalogue number Size Per pack Status
60023526 In distribution
ENDOBUNDLEXMOV 25 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Gentle Pulse™ Parkell, Inc. 11
Touch ‘n Heat Kerr Corporation 9
Digitest™ Parkell, Inc. 8
Vitality Scanner Kerr Corporation 7
Thermique™ Parkell, Inc. 6
Buchanan Plugger Ormco Corporation 6
Tester, Pulp Parkell, Inc. 6
Elements Ormco Corporation 5
Heat Carrier Ormco Corporation 4
Darby Dental Supply, LLC Darby Dental Supply, LLC 2
Elements Kerr Corporation 2
Patterson Patterson Dental Supply, Inc. 2

Showing 12 of 72. All products under Tester, Pulp

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