Pac-Dent

2 catalogue numbers from PE-VI-12, listed by PAC-Dent Inc., United States, under Tester, Pulp. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
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 Pac-Dent
Listed by PAC-Dent Inc., United States
FDA product code EAT
Device type Tester, Pulp
Device class Class 2
Regulation 21 CFR 872.1720
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2016-09-23
Record revised 2026-03-25 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date
Distribution end date 2026-03-24

Catalogue Numbers

Catalogue numbers for Pac-Dent
Catalogue number Size Per pack Status
PE-VI-12 12 Withdrawn
PE-VI-01 Withdrawn

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
CanalPro Coltene/Whaledent Gmbh & Co. KG 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