Henry Schein

Drills for Parallel-Sided Post Drill

Registry build 21.09.26
10manufacturers in China registered for this device type
133catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Guangdong (3), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EKP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Shanghai Smedent Medical Instrument Co., Ltd. Shanghai Shanghai Repacker / relabeller 30
Jinyuan Medical Equipment(Tianjin)Co., Ltd. Tianjin Tianjin Contract manufacturer 27
Bgss Company Asia Limited Zhabei Shanghai Contract manufacturer 25
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15
Innovative Material & Devices, Inc. Wuxi Jiangsu Contract manufacturer 13
Shenzhen Superline Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 12
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10

Record

Regulatory record for Henry Schein
Listed by Henry Schein, Inc., United States
FDA product code EKP
Device type Reamer, Pulp Canal, Endodontic
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2019-11-04

Specifications

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

Catalogue Numbers

Catalogue numbers for Henry Schein
Catalogue number Size Per pack Status
1005631 6 In distribution
1009919 6 In distribution
1006081 6 In distribution
1001974 6 In distribution
5701199 6 In distribution
1004759 6 In distribution
1007587 6 In distribution
5701203 6 In distribution
1008718 6 In distribution
1000218 In distribution
1007245 6 In distribution
1002426 6 In distribution
1000216 6 In distribution
1000190 6 In distribution
1001734 In distribution
1008840 6 In distribution
5701210 6 In distribution
5701219 6 In distribution
5701202 6 In distribution
1001212 6 In distribution
1008887 6 In distribution
1003321 6 In distribution
5701211 6 In distribution
5701215 6 In distribution
1006716 6 In distribution
1006876 6 In distribution
9006464 3 In distribution
1008400 6 In distribution
1001862 6 In distribution
1002481 6 In distribution
1002202 6 In distribution
1001733 6 In distribution
5701195 6 In distribution
1000661 6 In distribution
1002417 6 In distribution
1006481 6 In distribution
5701909 2 In distribution
1006092 6 In distribution
5701208 6 In distribution
1000399 6 In distribution
5701201 6 In distribution
5701193 6 In distribution
1013109 In distribution
1005170 6 In distribution
1011078 In distribution
1003420 6 In distribution
1007088 6 In distribution
5701910 2 In distribution
5701190 6 In distribution
1009935 6 In distribution
5701906 2 In distribution
5701907 2 In distribution
1000720 6 In distribution
1007090 6 In distribution
5701188 6 In distribution
9006462 3 In distribution
1007242 6 In distribution
1009385 6 In distribution
1007925 In distribution
1000284 6 In distribution
1006547 6 In distribution
1002993 6 In distribution
5701218 6 In distribution
5701198 6 In distribution
1006855 6 In distribution
1002410 6 In distribution
5701204 6 In distribution
1009592 6 In distribution
5701186 6 In distribution
1001097 6 In distribution
5701216 6 In distribution
1003236 6 In distribution
5701207 6 In distribution
1005973 6 In distribution
5701197 6 In distribution
1002996 6 In distribution
5701189 6 In distribution
5701185 6 In distribution
5701209 6 In distribution
1006541 6 In distribution
5701205 6 In distribution
5701191 6 In distribution
5701908 2 In distribution
5701206 6 In distribution
1005910 6 In distribution
1000583 6 In distribution
1002614 6 In distribution
5701196 6 In distribution
1001092 6 In distribution
5701212 6 In distribution
1000772 6 In distribution
1007558 6 In distribution
1003731 6 In distribution
5701220 6 In distribution
5701187 6 In distribution
5701192 6 In distribution
1009231 6 In distribution
1009385 6 In distribution
1005170 6 In distribution
1000661 6 In distribution
9006461 3 In distribution
1002541 6 In distribution
1002551 6 In distribution
1001854 6 In distribution
1002834 6 In distribution
5701217 6 In distribution
5701214 6 In distribution
5701213 6 In distribution
5701194 6 In distribution
5701905 2 In distribution
1008353 6 In distribution
9006463 3 In distribution
1003128 6 In distribution
1007169 6 In distribution
1008507 6 In distribution
1009219 6 In distribution
1002674 6 In distribution
1002895 6 In distribution
1000867 6 In distribution
5701904 2 In distribution
1006481 6 In distribution
1002671 6 In distribution
1006682 6 In distribution
1001410 6 In distribution
1008185 6 In distribution
1001317 6 In distribution
1009919 6 In distribution
1003811 6 In distribution
5701200 6 In distribution
1001437 6 In distribution
1004052 6 In distribution
1005065 In distribution
1003459 6 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Mani Reamers Mani, Inc. 106
K-Reamers Tulsa Dental Products LLC 103
Brasseler USA Peter Brasseler Holdings, LLC 82
K-Reamers Micro-Mega SA 72
M-access® K-Reamer Maillefer Instruments Holding Sàrl 69
Integra® Miltex® Integra LifeSciences Production Corporation 67
Mani Engine Reamers Mani, Inc. 64
Optimum Benco Dental Supply Co. 60
Darby Dental Supply, LLC Darby Dental Supply, LLC 60
Endodontic Hand Instruments Tulsa Dental Products LLC 49
SafeSiders Essential Dental Systems, Inc. 40
Endodontic Hand Instruments Roydent Dental Products, Inc. 28

Showing 12 of 195. All products under Reamer, Pulp Canal, Endodontic

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