Avalign

Double Ended Curette/Elevator, T/S

Registry build 21.09.26
1manufacturer
8catalogue numbers in this listing

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code EKT
Manufacturer City Province Registered as Device types
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54

Record

Regulatory record for Avalign
Listed by Avalign Technologies, Inc., United States
FDA product code EKT
Device type Curette, Endodontic
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-09-28
Record revised 2023-07-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Avalign
Catalogue number Size Status
VM99-1338 In distribution
VM99-1336 In distribution
VM99-1355 In distribution
VM99-1354 In distribution
VM99-1337 In distribution
VM99-1346 In distribution
VM99-1353 In distribution
VM99-1347 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ACE Ace Surgical Supply Co., Inc. 29
Millennium Avalign Technologies, Inc. 19
Pilling Teleflex Medical LLC 8
Nordent Manufacturing Inc Nordent Manufacturing Inc 7
TBS Basics Acme Enterprise. 4
Adler Instrument Company Adler, Inc. 3
Symmetry Lucas Aspen Surgical Products, Inc. 2
Symmetry Surgical Aspen Surgical Products, Inc. 2
devemed Devemed Gmbh 2
Symmetry Molt Aspen Surgical Products, Inc. 1
Integra® Miltex® Integra LifeSciences Production Corporation 1
Reicodent Devemed Gmbh 1

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