Power Dental USA

Pluggers/Condensers MOR2, (Same AS Item Code #3012, Duplicate Code)

Registry build 21.09.26
19manufacturers in China registered for this device type
82catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EKR
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Shanghai Smedent Medical Instrument Co., Ltd. Shanghai Shanghai Repacker / relabeller 30
CDM Center OF Excellence Ltd. Beijing Beijing Manufacturer 29
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15

Showing 12 of 19. All 19 manufacturers in China registered for Plugger, Root Canal, Endodontic

Record

Regulatory record for Power Dental USA
Listed by Power Dental U.S.A. Inc.
FDA product code EKR
Device type Plugger, Root Canal, Endodontic
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2021-07-13
Record revised 2025-05-08 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number
Distribution end date 2022-12-22

Catalogue Numbers

Catalogue numbers for Power Dental USA
Catalogue number Size Status
3332-2 In distribution
2309 In distribution
3413 In distribution
3410 In distribution
N3332 In distribution
3405 In distribution
3325 In distribution
3406 In distribution
2301S In distribution
2308 In distribution
3308 In distribution
3319 In distribution
3314 In distribution
2421T In distribution
3403 In distribution
2315 In distribution
3330 In distribution
3418 In distribution
2301 In distribution
3415 In distribution
3404 In distribution
2415TR In distribution
2303S In distribution
2322 In distribution
2410 In distribution
2307 In distribution
3408 In distribution
2304 In distribution
3332-1 In distribution
2304-EXP In distribution
2420T In distribution
3328 In distribution
2301T In distribution
2413T In distribution
3324 In distribution
3411 In distribution
3402 In distribution
3417 In distribution
3305 In distribution
3323 In distribution
3332D In distribution
3317 In distribution
3414 In distribution
3412 In distribution
3326 In distribution
2416 In distribution
3416 In distribution
3309 In distribution
3322 In distribution
3307 In distribution
3313 In distribution
3311 In distribution
3332-3 In distribution
2308T In distribution
2314 In distribution
2413TR In distribution
3409 In distribution
2407T In distribution
3401 In distribution
3306 In distribution
3327 In distribution
2303 In distribution
2422T In distribution
2302 In distribution
2307T In distribution
3332 In distribution
3320 In distribution
3310 In distribution
3329 In distribution
2404T In distribution
3312 In distribution
3318 In distribution
2304S In distribution
3316 In distribution
3321 In distribution
3315 In distribution
2415T In distribution
2311 In distribution
3407 In distribution
3331 In distribution
2308S In distribution
2411T Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 268
Brasseler USA Peter Brasseler Holdings, LLC 93
Integra® Miltex® Integra LifeSciences Production Corporation 69
Needle B&L Biotech Co., Inc. 40
American Eagle Instruments American Eagle Instruments 33
Henry Schein Henry Schein, Inc. 33
Premier Pluggers Premier Dental Products Co. 29
EQ-V Meta Systems Co., Ltd. 26
Obtura Spartan Young Innovations Inc. 25
Darby Dental Supply, LLC Darby Dental Supply, LLC 22
Nordent Manufacturing Inc Nordent Manufacturing Inc 22
Edge Endo Handpiece Parts & Repairs, Inc. 21

Showing 12 of 136. All products under Plugger, Root 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