ACE

Curette Implant Round Cups 5X10MM & 6X20MM 5-1/2" 14CM Titanium (6AL4V)

Registry build 21.09.26
1manufacturer
29catalogue 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 ACE
Listed by Ace Surgical Supply Co., Inc., United States
FDA product code EKT
Device type Curette, Endodontic
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2019-10-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Storage Special storage condition: No special storage conditions required
Sizes Length 5.5 to 7.5 in
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ACE
Catalogue number Size Status
1000237 Length 6.5 in In distribution
1000225 Length 6.5 in In distribution
1012232 Length 6.5 in In distribution
1000236 Length 7.5 in In distribution
9000011 Length 5.5 in In distribution
1013221 Length 6.5 in In distribution
1000202 Length 7 in In distribution
1000230 Length 6.5 in In distribution
1000204 Length 7 in In distribution
1000212 Length 7 in In distribution
0034194 In distribution
6301104 Length 7 in In distribution
1000234 Length 5.75 in In distribution
1000210 Length 7 in In distribution
1000244 Length 6.5 in In distribution
1000226 In distribution
1000221 Length 7 in In distribution
1000248 Length 7 in In distribution
1000231 Length 6.5 in In distribution
1000219 Length 6 in In distribution
1000220 Length 7 in In distribution
1000203 Length 7.25 in In distribution
1000209 Length 7 in In distribution
1000218 Length 6 in In distribution
1000205 Length 7 in In distribution
1000216 Length 5.5 in In distribution
1000211 Length 7 in In distribution
1000233 Length 6 in In distribution
1000206 Length 7 in In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 19
Pilling Teleflex Medical LLC 8
Avalign Avalign Technologies, Inc. 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