FDA UDI
In Commercial Distribution
🇺🇸 United States
Bosworth Aegis
DI: H66809213281
·
Model: 0921328
·
Harry J Bosworth Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Bosworth Aegis
- Primary DI
- H66809213281
- Version / Model
- 0921328
- Catalog Number
- 0921328
- Company Name
- Harry J Bosworth Company
- Labeler DUNS
- 014769301
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- 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
- 1409cacd-8c02-46e2-aa4e-dcaf039ca06e
Device Description
Aegis Pit & Fissure Sealant w/ACP Refill Kit
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 |
|---|---|---|---|---|
| EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER | Dental | 872.3765 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31780 | Dental pit/fissure sealant | A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H66809213281 | HIBCC | ||||
| Unit of Use | H66809213280 | HIBCC |
Customer Contacts
- Phone
- +1(800)333-3131 ext. 8455
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033751 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1.2 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from moisture
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight