Auradonics
EXTRAORAL LATEX-FREE ELASTICS 5/16" 8 oz. X-Hvy - CLEAR, 50 bags of 100, see www.auradonics.com
36manufacturers in China registered for this device type
743catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (8), Shanghai (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Zhejiang Risheng Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 8 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 36. All 36 manufacturers in China registered for Band, Elastic, Orthodontic
Record
| Listed by | Auradonics Incorporated, United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-12-30 |
| Record revised | 2021-06-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Away from sunlight or strong light; Storage environment temperature 6 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700-516 15 | In distribution | |
| 811-179NNL | In distribution | |
| 700-529 15 | In distribution | |
| 700-413 7.5 | In distribution | |
| 811-218 | In distribution | |
| 700-521 7.5 | In distribution | |
| 300-501 | In distribution | |
| 300-207 | In distribution | |
| 700-434 15 | In distribution | |
| 700-620 | In distribution | |
| 300-320 | In distribution | |
| 700-731 | In distribution | |
| 811-223 BLK | In distribution | |
| 300-401 BK | In distribution | |
| 300-708 | In distribution | |
| 300-404 | In distribution | |
| 811-130NL | In distribution | |
| 700-501 7.5 | In distribution | |
| 300-718 | In distribution | |
| 300-423 BK | In distribution | |
| 700-533 15 | In distribution | |
| 700-326 7.5 | In distribution | |
| 500-006 | In distribution | |
| 811-029NL | In distribution | |
| 811-306 | In distribution | |
| 812-023 OSE | In distribution | |
| 300-110 | In distribution | |
| 700-321 15 | In distribution | |
| 811-030 | In distribution | |
| 700-411 15 | In distribution | |
| 700-325 15 | In distribution | |
| 300-223 | In distribution | |
| 700-618 | In distribution | |
| 811-174NNL | In distribution | |
| 300-210 | In distribution | |
| 811-163NNL | In distribution | |
| 300-224 | In distribution | |
| 811-233 | In distribution | |
| 300-215 | In distribution | |
| 811-205 | In distribution | |
| 300-130 | In distribution | |
| 300-415 | In distribution | |
| 811-311 | In distribution | |
| 300-705 | In distribution | |
| 700-329 15 | In distribution | |
| 811-026 | In distribution | |
| 811-043 | In distribution | |
| 300-134 | In distribution | |
| 811-157NL | In distribution | |
| 811-228NNL | In distribution | |
| 811-233NNL | In distribution | |
| 700-417 15 | In distribution | |
| 811-209 | In distribution | |
| 811-019 BLK | In distribution | |
| 811-163 | In distribution | |
| 811-301 | In distribution | |
| 600-003 | In distribution | |
| 300-405 BK | In distribution | |
| 700-507 15 | In distribution | |
| 700-322 15 | In distribution | |
| 811-036NL | In distribution | |
| 300-712 | In distribution | |
| 700-427 15 | In distribution | |
| 300-732 | In distribution | |
| 700-523 15 | In distribution | |
| 300-429 BK | In distribution | |
| 700-327 7.5 | In distribution | |
| 300-103 | In distribution | |
| 700-320 7.5 | In distribution | |
| 811-224 | In distribution | |
| 811-021 BLK | In distribution | |
| 700-314 7.5 | In distribution | |
| 812-157 OSE | In distribution | |
| 700-312 7.5 | In distribution | |
| 300-211 | In distribution | |
| 811-313 | In distribution | |
| 700-508 15 | In distribution | |
| 811-028NL | In distribution | |
| 300-709 | In distribution | |
| 700-530 15 | In distribution | |
| 811-041NNL | In distribution | |
| 811-015 | In distribution | |
| 811-126 | In distribution | |
| 300-218 | In distribution | |
| 300-401 | In distribution | |
| 811-055NL | In distribution | |
| 811-162NNL | In distribution | |
| 300-206 | In distribution | |
| 700-415 7.5 | In distribution | |
| 811-010NL | In distribution | |
| 811-221 | In distribution | |
| 700-531 15 | In distribution | |
| 811-128 | In distribution | |
| 700-519 7.5 | In distribution | |
| 700-414 15 | In distribution | |
| 700-334 15 | In distribution | |
| 811-212NL | In distribution | |
| 700-420 7.5 | In distribution | |
| 811-033NL | In distribution | |
| 811-177NNL | In distribution | |
| 811-213 | In distribution | |
| 811-300 | In distribution | |
| 300-425 BK | In distribution | |
| 811-064NL | In distribution | |
| 500-004 | In distribution | |
| 700-402 15 | In distribution | |
| 700-400 15 | In distribution | |
| 300-419 BK | In distribution | |
| 811-229 | In distribution | |
| 811-211NL | In distribution | |
| 811-211 | In distribution | |
| 811-227 | In distribution | |
| 300-112 | In distribution | |
| 300-310 | In distribution | |
| 700-431 7.5 | In distribution | |
| 811-210NL | In distribution | |
| 300-427 | In distribution | |
| 500-007 | In distribution | |
| 811-304 | In distribution | |
| 811-041 | In distribution | |
| 811-056NL | In distribution | |
| 700-408 7.5 | In distribution | |
| 811-170 | In distribution | |
| 300-204 | In distribution | |
| 700-300 7.5 | In distribution | |
| 700-404 15 | In distribution | |
| 811-057 | In distribution | |
| 700-523 7.5 | In distribution | |
| 300-115 | In distribution | |
| 700-432 15 | In distribution | |
| 700-308 15 | In distribution | |
| 300-131 | In distribution | |
| 811-125 | In distribution | |
| 700-308 7.5 | In distribution | |
| 811-013NL | In distribution | |
| 300-118 | In distribution | |
| 811-172NNL | In distribution | |
| 811-008NL | In distribution | |
| 811-014 | In distribution | |
| 500-005 | In distribution | |
| 300-400 BK | In distribution | |
| 700-405 7.5 | In distribution | |
| 811-007NL | In distribution | |
| 811-054 | In distribution | |
| 811-060 | In distribution | |
| 811-013 | In distribution | |
| 300-306 | In distribution | |
| 811-042 | In distribution | |
| 700-533 7.5 | In distribution | |
| 811-173 | In distribution | |
| 811-038 | In distribution | |
| 811-130 | In distribution | |
| 700-410 15 | In distribution | |
| 811-027NL | In distribution | |
| 300-227 | In distribution | |
| 811-027 | In distribution | |
| 700-404 7.5 | In distribution | |
| 811-314 | In distribution | |
| 700-504 15 | In distribution | |
| 811-058 | In distribution | |
| 700-419 7.5 | In distribution | |
| 811-208NL | In distribution | |
| 300-128 | In distribution | |
| 700-303 7.5 | In distribution | |
| 700-513 15 | In distribution | |
| 700-311 7.5 | In distribution | |
| 700-421 15 | In distribution | |
| 811-200NL | In distribution | |
| 811-048NNL | In distribution | |
| 600-002 | In distribution | |
| 811-007 | In distribution | |
| 811-175 | In distribution | |
| 700-524 15 | In distribution | |
| 811-030NL | In distribution | |
| 700-500 15 | In distribution | |
| 811-164 | In distribution | |
| 300-402 | In distribution | |
| 700-645 | In distribution | |
| 300-327 | In distribution | |
| 812-009 OSE | In distribution | |
| 700-416 15 | In distribution | |
| 700-525 7.5 | In distribution | |
| 811-158NL | In distribution | |
| 811-234 | In distribution | |
| 700-430 15 | In distribution | |
| 812-004 OSE | In distribution | |
| 300-416 BK | In distribution | |
| 300-232 | In distribution | |
| 700-630 | In distribution | |
| 300-304 | In distribution | |
| 700-503 7.5 | In distribution | |
| 812-155 OSE | In distribution | |
| 700-328 7.5 | In distribution | |
| 811-045 | In distribution | |
| 300-229 | In distribution | |
| 700-423 15 | In distribution | |
| 811-050 | In distribution | |
| 811-019 | In distribution | |
| 700-319 15 | In distribution | |
| 300-407 | In distribution | |
| 811-003 | In distribution | |
| 811-164NNL | In distribution | |
| 300-711 | In distribution | |
| 300-703 | In distribution | |
| 300-733 | In distribution | |
| 700-317 7.5 | In distribution | |
| 700-321 7.5 | In distribution | |
| 300-431 BK | In distribution | |
| 300-200MP | In distribution | |
| 700-407 7.5 | In distribution | |
| 811-229NNL | In distribution | |
| 300-208 | In distribution | |
| 700-302 7.5 | In distribution | |
| 700-304 7.5 | In distribution | |
| 700-420 15 | In distribution | |
| 700-514 15 | In distribution | |
| 811-202 | In distribution | |
| 811-222NNL | In distribution | |
| 700-403 15 | In distribution | |
| 700-512 7.5 | In distribution | |
| 700-326 15 | In distribution | |
| 700-424 7.5 | In distribution | |
| 700-534 15 | In distribution | |
| 811-173NNL | In distribution | |
| 700-330 7.5 | In distribution | |
| 300-432 BK | In distribution | |
| 300-421 BK | In distribution | |
| 700-520 15 | In distribution | |
| 811-018 | In distribution | |
| 300-422 BK | In distribution | |
| 811-205NL | In distribution | |
| 700-433 15 | In distribution | |
| 700-725 | In distribution | |
| 300-225 | In distribution | |
| 300-123 | In distribution | |
| 300-430 | In distribution | |
| 812-156 OSE | In distribution | |
| 811-171 | In distribution | |
| 811-072NL | In distribution | |
| 811-316 | In distribution | |
| 300-132 | In distribution | |
| 300-428 | In distribution | |
| 811-221NNL | In distribution | |
| 300-430 BK | In distribution | |
| 811-204 | In distribution | |
| 700-311 15 | In distribution | |
| 812-008 OSE | In distribution | |
| 811-017 | In distribution | |
| 811-040NNL | In distribution | |
| 300-404 BK | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advance Dental Products | THE Atlanta Dental Supply Company | 312 |
| Conlin Molar Band | Ortho Arch Company Inc | 308 |
| Elastic Chain | Ortho Organizers, Inc. | 248 |
| Ligatures | American Orthodontics | 233 |
| 3M™ AlastiK™ | 3M Unitek | 220 |
| Morelli | Dental Morelli Ltda. | 207 |
| Mirabay | Mirabay Orthodontics Corporation | 185 |
| Orthometric Elastomerics – Chain | Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda | 182 |
| Maximum | Ortho Technology, Inc. | 177 |
| Halo Molar Band | Ortho Arch Company Inc | 177 |
| Colored Chain | American Orthodontics | 168 |
| The Orthodontic Store | Young Innovations Inc. | 155 |
Showing 12 of 474. All products under Band, Elastic, Orthodontic
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.