Wildlife
Elastics Wildlife Gorilla Assort Neon Medium 4.5 OZ 3/16" 100/BAG
36manufacturers in China registered for this device type
140catalogue numbers in this listing
1510(k) clearance
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 | American Orthodontics, United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-10-05 |
| Record revised | 2025-04-01 (version 7) |
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 | Storage environment humidity 0 to 80 % RH; Special storage condition: Keep Away from Light; Storage environment temperature 10 to 25 °C |
| Distribution end date | 2025-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000-103BAG | In distribution | |
| 000-112SBAG | In distribution | |
| 000-102BAG | In distribution | |
| 000-132BAG | In distribution | |
| 000-107 | In distribution | |
| 080-025 | In distribution | |
| 000-111 | In distribution | |
| 000-110S | In distribution | |
| 000-107BAG | In distribution | |
| 000-134 | In distribution | |
| 000-120BAG | In distribution | |
| 854-114 | In distribution | |
| 000-112S | In distribution | |
| 000-105SBAG | In distribution | |
| 000-145 | In distribution | |
| 000-101 | In distribution | |
| 854-122 | In distribution | |
| 000-124 | In distribution | |
| 000-143BAG | In distribution | |
| 000-111CBAG | In distribution | |
| 000-120CBAG | In distribution | |
| 000-123C | In distribution | |
| 000-113 | In distribution | |
| 000-103S | In distribution | |
| 000-133 | In distribution | |
| 000-112CBAG | In distribution | |
| 000-132 | In distribution | |
| 000-106 | In distribution | |
| 000-123BAG | In distribution | |
| 000-121BAG | In distribution | |
| 000-105 | In distribution | |
| 000-131 | In distribution | |
| 854-113 | In distribution | |
| 000-143 | In distribution | |
| 000-111SBAG | In distribution | |
| 000-122CBAG | In distribution | |
| 004-116 | In distribution | |
| 004-115 | In distribution | |
| 000-113C | In distribution | |
| 000-114BAG | In distribution | |
| 000-110BAG | In distribution | |
| 080-040 | In distribution | |
| 000-104 | In distribution | |
| 854-121 | In distribution | |
| 000-122 | In distribution | |
| 000-111C | In distribution | |
| 080-030BAG | In distribution | |
| 000-104S | In distribution | |
| 000-114 | In distribution | |
| 000-102 | In distribution | |
| 000-122C | In distribution | |
| 000-101S | In distribution | |
| 000-133BAG | In distribution | |
| 854-123 | In distribution | |
| 000-101BAG | In distribution | |
| 080-035 | In distribution | |
| 000-121C | In distribution | |
| 000-120C | In distribution | |
| 080-025BAG | In distribution | |
| 854-110 | In distribution | |
| 000-145BAG | In distribution | |
| 000-101SBAG | In distribution | |
| 000-110C | In distribution | |
| 000-105BAG | In distribution | |
| 000-103SBAG | In distribution | |
| 854-120 | In distribution | |
| 000-122BAG | In distribution | |
| 000-103 | In distribution | |
| 000-121CBAG | In distribution | |
| 854-124 | In distribution | |
| 000-105S | In distribution | |
| 000-112 | In distribution | |
| 000-120 | In distribution | |
| 000-112C | In distribution | |
| 000-102S | In distribution | |
| 854-112 | In distribution | |
| 080-035BAG | In distribution | |
| 000-113BAG | In distribution | |
| 000-110 | In distribution | |
| 000-104SBAG | In distribution | |
| 000-123CBAG | In distribution | |
| 000-134BAG | In distribution | |
| 000-124BAG | In distribution | |
| 000-110SBAG | In distribution | |
| 000-123 | In distribution | |
| 854-111 | In distribution | |
| 004-107 | In distribution | |
| 000-131BAG | In distribution | |
| 000-106BAG | In distribution | |
| 000-111S | In distribution | |
| 080-040BAG | In distribution | |
| 000-104BAG | In distribution | |
| 000-124SBAG | In distribution | |
| 000-113CBAG | In distribution | |
| 000-110CBAG | In distribution | |
| 080-030 | In distribution | |
| 004-106 | In distribution | |
| 000-121 | In distribution | |
| 000-112BAG | In distribution | |
| 000-111BAG | In distribution | |
| 000-102SBAG | In distribution | |
| 000-101SBAG | Withdrawn | |
| 854-116 | Withdrawn | |
| BULK-124 | Withdrawn | |
| 000-124SBAG | Withdrawn | |
| 000-113SBAG | Withdrawn | |
| 000-145 | Withdrawn | |
| 000-110SBAG | Withdrawn | |
| 000-123SBAG | Withdrawn | |
| 000-123SBAG | Withdrawn | |
| 000-114SBAG | Withdrawn | |
| 854-115 | Withdrawn | |
| 000-114SBAG | Withdrawn | |
| 000-124S | Withdrawn | |
| 000-105SBAG | Withdrawn | |
| 000-120SBAG | Withdrawn | |
| 000-143 | Withdrawn | |
| 000-104SBAG | Withdrawn | |
| 000-121SBAG | Withdrawn | |
| 000-111SBAG | Withdrawn | |
| 000-114S | Withdrawn | |
| 000-122SBAG | Withdrawn | |
| 000-113SBAG | Withdrawn | |
| 000-122S | Withdrawn | |
| 000-103SBAG | Withdrawn | |
| 000-102SBAG | Withdrawn | |
| 000-121SBAG | Withdrawn | |
| BULK-123 | Withdrawn | |
| 000-120S | Withdrawn | |
| 000-112SBAG | Withdrawn | |
| BULK-122 | Withdrawn | |
| 000-123S | Withdrawn | |
| BULK-103 | Withdrawn | |
| 854-107 | Withdrawn | |
| BULK-132 | Withdrawn | |
| 000-113S | Withdrawn | |
| 000-122SBAG | Withdrawn | |
| 854-106 | Withdrawn | |
| 000-120SBAG | Withdrawn | |
| 000-121S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Auradonics | Auradonics Incorporated | 743 |
| 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 |
Showing 12 of 474. All products under Band, Elastic, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K926578 | 1993-03-31 |
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.