Dalbo®-PLUS

Dalbo®-PLUS Tuning lamellae retention insert extra-forte E

Registry build 21.09.26
1manufacturer
18catalogue numbers in this listing

Who Else Makes It

Registered in Hunan.

Chinese manufacturers registered for FDA product code EJX
Manufacturer City Province Registered as Device types
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17

Record

Regulatory record for Dalbo®-PLUS
Listed by Cendres+Métaux SA
FDA product code EJX
Device type Anchor, Preformed
Device class Class 1
Regulation 21 CFR 872.3130
Premarket notification Exempt
Record published 2020-01-06
Record revised 2021-06-11 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Storage Special storage condition: Keep away from sunlight

Catalogue Numbers

Catalogue numbers for Dalbo®-PLUS
Catalogue number Size Status
05000215 In distribution
055760 In distribution
055752 In distribution
05001240 In distribution
055687 In distribution
055771 In distribution
055750 In distribution
055643 In distribution
05000081 In distribution
055891 In distribution
05000214 In distribution
05000068 In distribution
05003503 In distribution
055890 In distribution
055889 In distribution
05003504 In distribution
05001242 In distribution
05000083 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Dalbo®-Z Cendres+Métaux SA 4
Gerber RZ Cendres+Métaux SA 3
Smileloc® BY Rodo Rodo Medical, Inc 3
Dalbo®-B Cendres+Métaux SA 2
Leixir Recharge Kit, Unigrip Smart Denture Conversions, LLC 1
Tall Spare Parts Kit, Omnibut Smart Denture Conversions, LLC 1
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Showing 12 of 79. All products under Anchor, Preformed

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