GC Ortho Etching Gel
- Primary DI
- E53590140000001
- Brand
- GC Ortho Etching Gel
- Company
- Gc Orthodontics America Inc.
- Model
- 90-1400-0000
- Catalog number
- 90-1400-0000
- Device description
- GC Ortho Etching Gel 2 syringe pack
- Published
- 2016-08-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
gcorthodontics.comProduct Codes#
| Code | Name |
|---|---|
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K150128 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| E53590140000001 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental etching solution | An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 39 Degrees Fahrenheit | 77 Degrees Fahrenheit |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(708)897-8859 | GCOAInfo@gcorthodontics.com |
Regulatory Flags#
- DUNS number
- 063167128
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10840539702450 | Experience | 50-0300-0000 | 50-0300-0000 | 2026-05-28 |
| 10860013564701 | Curva | 50-0041-0000 | 50-0041-0000 | 2026-05-28 |
| 10860013564718 | Curva | 50-0040-0000 | 50-0041-0000 | 2026-05-28 |
| 10860013564725 | Curva | 50-0512-0000 | 50-0041-0000 | 2026-05-28 |
| 10860013564732 | Curva | 50-0513-0000 | 50-0041-0000 | 2026-05-28 |
| 10860013564756 | Curva | 50-5610-0000 | 50-0041-0000 | 2026-05-28 |
| 10860013564763 | Curva | 50-5000-0000 | 50-0041-0000 | 2026-05-28 |
| 10860013564770 | Curva | 50-0043-0000 | 50-0041-0000 | 2026-05-28 |
| 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 |
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