FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BIOSEAL
DI: 00766054002949
·
Model: 1640-00
·
ESSENTIAL DENTAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOSEAL
- Primary DI
- 00766054002949
- Version / Model
- 1640-00
- Catalog Number
- 1640-00
- Company Name
- ESSENTIAL DENTAL SYSTEMS, INC.
- Labeler DUNS
- 101147171
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-31
- Public Version
- 1
- Public Version Date
- 2024-11-08
- Public Version Status
- New
- Public Device Record Key
- 36b9f2bb-d542-44ce-8188-9976e175d68e
- Distribution End Date
- 2024-11-06
Device Description
Bioceramic Endodontic Sealer
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
- Yes
- 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 |
|---|---|---|---|---|
| KIF | RESIN, ROOT CANAL FILLING | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60510 | Hygroscopic dental cement | A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00766054002949 | GS1 |
Customer Contacts
- Phone
- +1(201)487-9090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202281 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 25 – 77 Degrees Fahrenheit