FDA UDI
In Commercial Distribution
🇺🇸 United States
Bosworth SuperEBA
DI: H66809210101
·
Model: 0921010
·
Harry J Bosworth Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bosworth SuperEBA
- Primary DI
- H66809210101
- Version / Model
- 0921010
- Catalog Number
- 0921010
- Company Name
- Harry J Bosworth Company
- Labeler DUNS
- 014769301
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c9628a90-443b-47dc-b33d-224f5224ef2b
Device Description
6.5 ml ZOE Cement Liquid
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| EMA | CEMENT, DENTAL | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16703 | Ethoxy benzoic acid dental cement | A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between ethoxy benzoic acid (EBA) and zinc oxide (ZnO). It typically includes some additional fillers/components. 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 | H66809210101 | HIBCC |
Customer Contacts
- Phone
- +1(800)333-3131 ext. 8455
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983752 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 6.5 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from moisture
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight