Avalign

Periosteal Elevator, curved blade, blunt,

Registry build 21.09.26
6manufacturers in China registered for this device type
44catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EMJ
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17

Record

Regulatory record for Avalign
Listed by Avalign Technologies, Inc., United States
FDA product code EMJ
Device type Elevator, Surgical, Dental
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
VM99-1424 In distribution
VM99-1289 In distribution
VM99-1423 In distribution
VM99-1405 In distribution
VM95-0091 In distribution
VM99-1413 In distribution
VM83-2119 In distribution
VM99-1688 In distribution
VM95-0093 In distribution
VM99-1395 In distribution
VM96-1965 In distribution
VM99-1489 In distribution
VM96-1315 In distribution
VM95-0089 In distribution
VM96-1311 In distribution
VM99-1479 In distribution
VM99-1404 In distribution
VM99-1391 In distribution
VM96-1217 In distribution
VM99-1407 In distribution
VM99-1422 In distribution
VM99-1687 In distribution
VM99-1487 In distribution
VM99-1444 In distribution
VM99-1203 In distribution
VM99-1434 In distribution
VM99-1451 In distribution
VM99-1304 In distribution
VM99-1412 In distribution
VM96-1299 In distribution
VM99-1453 In distribution
VM99-1497 In distribution
VM99-1470 In distribution
VM99-1433 In distribution
VM99-1445 In distribution
VM99-1493 In distribution
VM96-1319 In distribution
VM99-1309 In distribution
VM99-1396 In distribution
VM99-1443 In distribution
VM96-1567 In distribution
VM99-1415 In distribution
VM95-0095 In distribution
VM99-1452 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 465
Nordent Manufacturing Inc Nordent Manufacturing Inc 264
Power Dental USA Power Dental U.S.A. Inc. 247
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 233
Elevator KLS-Martin L.P. 231
Kohdent Kohler Medizintechnik GmbH 206
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 153
Stoma® Storz AM Mark Gmbh 150
Reicodent Devemed Gmbh 142
Sklar Sklar Corporation 130
Osung MND Osung MND Co., Ltd. 126
Karl Schumacher Karl Schumacher Dental, LLC 121

Showing 12 of 743. All products under Elevator, Surgical, Dental

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