Sklar®

Mouth Mirror Size 5 SS FRT SF BX12

Registry build 21.09.26
94manufacturers in China registered for this device type
60catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (23), Shanghai (15), Jiangsu (14). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EAX
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Shun SZE Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 22
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Yangzhou Haiwang Toothbrush Factory Yangzhou Jiangsu Contract manufacturer 12
Coda Resources Ltd., Heze China Heze Shandong Contract manufacturer 9
Perfect Group Corp. Ltd. Yangzhou Jiangsu Contract manufacturer 9
Dongguan Shun King Company Limited Dongguan Guangdong Contract manufacturer 4
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Showing 12 of 94. All 94 manufacturers in China registered for Mirror, Mouth

Record

Regulatory record for Sklar®
Listed by Sklar Corporation, United States
FDA product code EAX
Device type Mirror, Mouth
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-11-20
Record revised 2018-10-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Sklar®
Catalogue number Size Per pack Status
41-166 12 In distribution
73-1376 In distribution
73-1189 In distribution
73-1375 In distribution
73-1475 12 In distribution
41-106 12 In distribution
73-1465 12 In distribution
73-1372 In distribution
73-1525 12 In distribution
73-1540 12 In distribution
73-1415 In distribution
73-1378 In distribution
73-1420 In distribution
73-1197 In distribution
73-1196 In distribution
41-142 12 In distribution
73-1455 12 In distribution
73-1289 In distribution
41-172 12 In distribution
41-136 12 In distribution
41-155 12 In distribution
41-104 12 In distribution
73-1500 12 In distribution
73-1510 12 In distribution
73-1505 12 In distribution
73-1193 In distribution
41-123 12 In distribution
73-1190 In distribution
73-1485 12 In distribution
73-1303 In distribution
73-1470 12 In distribution
73-1520 12 In distribution
41-125 12 In distribution
73-1495 12 In distribution
21-987 12 In distribution
93-1142 12 In distribution
41-170 12 In distribution
73-1480 12 In distribution
73-1530 12 In distribution
73-1353 In distribution
73-1405 In distribution
73-1192 In distribution
73-1400 In distribution
73-1460 12 In distribution
73-1373 In distribution
73-1550 12 In distribution
73-1545 12 In distribution
73-1515 12 In distribution
73-1535 12 In distribution
73-1450 12 In distribution
73-1195 In distribution
73-1374 In distribution
73-1191 In distribution
73-1194 In distribution
73-1188 In distribution
73-1371 In distribution
73-1490 12 In distribution
73-1377 In distribution
73-1410 In distribution
73-1294 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
E. Hahnenkratt GmbH E. Hahnenkratt Gmbh 118
Hahnenkratt E. Hahnenkratt Gmbh 108
Integra® Miltex® Integra LifeSciences Production Corporation 86
Crystal HD® Mouth Mirrors Zirc Dental Products, Inc. 65
HU-Friedy HU-Friedy MFG Co., LLC 59
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 43
Osung MND Osung MND Co., Ltd. 39
Mouth Mirror Handle Zirc Dental Products, Inc. 33
Jedmed Jedmed Instrument Company 31
Plasdent Plasdent Corp. 30
Henry Schein Henry Schein, Inc. 27
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 26

Showing 12 of 205. All products under Mirror, Mouth

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