Dispos-a-Bite

Disposable bite blocks Fits Phillips DenTalEz Panolite Soredex

Registry build 21.09.26
2manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (1), Tianjin (1).

Chinese manufacturers registered for FDA product code EHA
Manufacturer City Province Registered as Device types
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Jinyuan Medical Equipment(Tianjin)Co., Ltd. Tianjin Tianjin Contract manufacturer 27

Record

Regulatory record for Dispos-a-Bite
Listed by Metrex Research, United States
FDA product code EHA
Device type Aligner, Beam, X-Ray
Device class Class 1
Regulation 21 CFR 872.1820
Establishment Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2016-08-31
Record revised 2020-10-21 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Dispos-a-Bite
Catalogue number Size Per pack Status
7040 100 In distribution
7010 100 In distribution
7030 100 In distribution
7020 100 In distribution
7000 100 In distribution
7070 100 In distribution
7095 100 In distribution
7085 100 In distribution
7090 100 In distribution
7050 100 In distribution
7060 100 In distribution
7080 100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rinn® Dentsply LLC 37
Schick Dentsply LLC 5
Bar, Alignment, Universal Dental Imaging Technologies Corporation 2
Endodontic Bar – Alignment Bar Dental Imaging Technologies Corporation 1
Cranex 3D PAT Posit Accessories Palodex Group OY 1
Bite blocks 10pcs OP 3D Palodex Group OY 1
Intraoral Sensor Holders Arms and Rings Sirona Dental, Inc. 1
Cranex 3D PAN Accessories Palodex Group OY 1
Bite Block (SET OF 10 PCS) Palodex Group OY 1
Intraoral Sensor Holder Arms and Rings Sirona Dental, Inc. 1
Bar, Alignment, Bitewing, Dexis Dental Imaging Technologies Corporation 1
Bar, Alignment, Bitewing, Short Dental Imaging Technologies Corporation 1

Showing 12 of 20. All products under Aligner, Beam, X-Ray

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