SURE-SNAP
- Primary DI
- E53580162000001
- Brand
- SURE-SNAP
- Company
- Gc Orthodontics America Inc.
- Model
- 80-1620-0000
- Catalog number
- 80-1620-0000
- Device description
- SURE-SNAP 1. MOLAR UPR RGT SZ 20
- Published
- 2017-06-30
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
gcorthodontics.comProduct Codes#
| Code | Name |
|---|---|
| DYO | BAND, MATERIAL, ORTHODONTIC |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYO | Band, Material, Orthodontic | Dental | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| E53580162000001 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthodontic metal band | A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(708)897-8859 | GCOAInfo@gcorthodontics.com |
Regulatory Flags#
- DUNS number
- 063167128
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D78887122400001 | GC Ties | 87-1224-0000 | 87-1224-0000 | 2021-08-26 |
| D78887122500001 | GC Ties | 87-1225-0000 | 87-1225-0000 | 2021-08-26 |
| D78887122600001 | GC Ties | 87-1226-0000 | 87-1226-0000 | 2021-08-26 |
| D78887122700001 | GC Ties | 87-1227-0000 | 87-1227-0000 | 2021-08-26 |
| D78887122800001 | GC Ties | 87-1228-0000 | 87-1228-0000 | 2021-08-26 |
| D78887122900001 | GC Ties | 87-1229-0000 | 87-1229-0000 | 2021-08-26 |
| D78887123000001 | GC Ties | 87-1230-0000 | 87-1230-0000 | 2021-08-26 |
| D78887123100001 | GC Ties | 87-1231-0000 | 87-1231-0000 | 2021-08-26 |
| D78887123200001 | GC Ties | 87-1232-0000 | 87-1232-0000 | 2021-08-26 |
| D78887123300001 | GC Ties | 87-1233-0000 | 87-1233-0000 | 2021-08-26 |
| D78887123400001 | GC Ties | 87-1234-0000 | 87-1234-0000 | 2021-08-26 |
| D78887123500001 | GC Ties | 87-1235-0000 | 87-1235-0000 | 2021-08-26 |
| E53585043111111 | ELASTICS | 85-0431-1111 | 95-0431-1111 | 2021-08-26 |
| E53585044111111 | ELASTICS | 85-0441-1111 | 85-0441-1111 | 2021-08-26 |
| E53585063111111 | ELASTICS | 85-0631-1111 | 85-0631-1111 | 2021-08-26 |
| E53585064111111 | ELASTICS | 85-0641-1111 | 96-0641-1111 | 2021-08-26 |
| E53585083111111 | ELASTICS | 85-0831-1111 | 85-0831-1111 | 2021-08-26 |
| E53585084111111 | ELASTICS | 85-0841-1111 | 85-0841-1111 | 2021-08-26 |
| D78889312200001 | ELASTIC THREAD | 89-3122-0000 | 89-3122-0000 | 2021-12-03 |
| D78889313200001 | ELASTIC THREAD | 89-3132-0000 | 89-3132-0000 | 2021-12-03 |
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| 06974720061211 | Dental Sheet | Sichuan Yaqi Medical Technology Co., Ltd. | DYO | 2026-05-21 |
| 06974720061228 | Dental Sheet | Sichuan Yaqi Medical Technology Co., Ltd. | DYO | 2026-05-21 |
| 06974720061235 | Dental Sheet | Sichuan Yaqi Medical Technology Co., Ltd. | DYO | 2026-05-21 |
| 06974720061242 | Dental Sheet | Sichuan Yaqi Medical Technology Co., Ltd. | DYO | 2026-05-21 |
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