FDA UDI
In Commercial Distribution
🇺🇸 United States
Ormco™ EtchFree Bonding
DI: 00889989088908
·
Model: 740-0520
·
ORMCO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ormco™ EtchFree Bonding
- Primary DI
- 00889989088908
- Version / Model
- 740-0520
- Company Name
- ORMCO CORPORATION
- Labeler DUNS
- 154614119
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-09
- Public Version
- 1
- Public Version Date
- 2025-05-19
- Public Version Status
- New
- Public Device Record Key
- 61d5caf5-cd96-4505-9d40-866024840bbb
Device Description
ORMCO ETCHFREE BONDING STARTER KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | Dental | 872.3750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31750 | Orthodontic bracket adhesive | A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889989088908 | GS1 |
Customer Contacts
- Phone
- +18008541741
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 80 Degrees Fahrenheit