A-Dec

A-dec Smart-Air 12 is an oil-free compressor for a dental treatment unit. The compressor supplies compressed air to connected dental equipment that uses an air supply during operation. The…

Registry build 21.09.26

A-dec Smart-Air 12 is an oil-free compressor for a dental treatment unit. The compressor supplies compressed air to connected dental equipment that uses an air supply during operation.

The filed configuration names a Hexad motor. This product is the compressor component in the dental equipment system, not a vacuum source or a complete treatment unit.

Listed Item

Smart-Air 12 – Hexad motor Oil-Free Compressor

Air Supply Role

The compressor supplies pressurized air to connected dental-unit attachments that require an air source. Its oil-free design identifies how the compressor provides that supply.

Smart-Air 12 is the compressor component in a dental treatment setup. It supports the operation of connected air-driven equipment as part of the larger unit.

65manufacturers in China registered for this device type
19catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (15), Shanghai (9), Hebei (8). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NRD
Manufacturer City Province Registered as Device types
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Shanghai Greeloy Industry Co., Ltd. Shanghai Shanghai Contract manufacturer 9
Yangzhou Star Oral Care Product Co., Ltd. Yangzhou Jiangsu Contract manufacturer 7
Dacheng Huaguan Dental Instruments Co., Ltd. Langfang Hebei Contract manufacturer 4
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99

Showing 12 of 65. All 65 manufacturers in China registered for Unit, Operative Dental, Accessories

Record

Regulatory record for A-dec
Listed by A-dec, Inc., United States
FDA product code NRD
Device type Unit, Operative Dental, Accessories
Device class Class 1
Regulation 21 CFR 872.6640
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-11-09
Record revised 2023-04-26 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for A-dec
Catalogue number Size Status
SC10 In distribution
SC12 In distribution
SC3 In distribution
DV10 In distribution
DV5plus In distribution
SC12plus In distribution
DV12plus In distribution
SC3plus In distribution
DV7plus In distribution
DV5 In distribution
SC5 In distribution
SC5plus In distribution
DV10plus In distribution
WSV In distribution
SC10plus In distribution
DV12 In distribution
SC7 In distribution
DV7 In distribution
SC7plus In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Plasdent Plasdent Corp. 409
Midmark Midmark Corporation 106
BaseVac R.E. Morrison Equipment Inc 70
Unipack Unipack LLC 51
Mojave AIR Techniques, Inc. 50
AirStar AIR Techniques, Inc. 48
Premium Plus Premium Plus International Limited 47
Top Quality Manufacturing TOP Quality Manufacturing, Inc. 38
Benco Benco Dental Supply Co. 37
Ramvac Dentalez Alabama, Inc. 32
VacStar AIR Techniques, Inc. 29
Safe Dent Bgss Company Inc 22

Showing 12 of 107. All products under Unit, Operative Dental, Accessories

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