BC Sealer
- Primary DI
- 08404535011982
- Brand
- BC Sealer
- Company
- Peter Brasseler Holdings, LLC
- Model
- 5031698U0
- Device description
- BC SEALER SOLVENT 8OZ
- Published
- 2025-03-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KJJ | CLEANSER, ROOT CANAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KJJ | Cleanser, Root Canal | Unknown | U |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08404535011982 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08404535011982 | 08404535011982 | 8404535011982 |
GMDN Terms
| Term | Definition |
|---|
| Root canal cleaning solution | A fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placement of the endodontic filling; it may also act as a lubricant to facilitate the passage of an instrument (e.g., file/rasp) into the root canal. It is typically available as a disinfecting solution (e.g., chlorhexidine, sodium hypochlorite solution) delivered into the canal with an irrigation needle, or similar device, providing mechanical and possibly chemical cleaning of the canal. After application, this device cannot be reused. |
Regulatory Flags
- DUNS number
- 082080136
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
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|---|
| 00810126506221 | 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | KJJ | 2026-03-24 |
| 00810118106415 | Avalon Biomed NeoSolv | NUSMILE, LTD. | KJJ | 2025-03-19 |
| 00810118106422 | Avalon Biomed NeoSolv | NUSMILE, LTD. | KJJ | 2025-03-19 |
| 10818207024937 | EdgeUtopi BC Solvent | Vista Dental | KJJ | 2025-03-17 |
| 10810138823276 | RC Mix | Endo Direct LLC | KJJ | 2025-03-03 |
| D6620708377810 | Patterson® | PATTERSON DENTAL SUPPLY, INC. | KJJ | 2024-05-08 |
| D6620708377990 | Patterson® | PATTERSON DENTAL SUPPLY, INC. | KJJ | 2024-05-08 |
| 00840326420331 | Young PerioDT | Young Innovations, Inc. | KJJ | 2023-10-05 |
| 00840326420355 | Young PerioDT | Young Innovations, Inc. | KJJ | 2023-10-05 |
| 00840326420379 | Young PerioDT | Young Innovations, Inc. | KJJ | 2023-10-05 |
| 00840326420393 | Young PerioDT | Young Innovations, Inc. | KJJ | 2023-10-05 |
| 07630031730053 | Straumann PrefGel | Institut Straumann AG | KJJ | 2023-09-30 |
| 10810138822668 | Endo Direct Sodium hypoclorite 3% | Endo Direct LLC | KJJ | 2023-07-15 |
| 10810138822675 | Endo Direct Sodium hypoclorite 6% | Endo Direct LLC | KJJ | 2023-07-15 |
| 10810138822682 | Endo Direct 17% EDTA | Endo Direct LLC | KJJ | 2023-07-15 |
| 00818365028870 | EdgeMix™ | US ENDODONTICS, LLC | KJJ | 2023-06-25 |
| 00818365028979 | EdgeEndo® | US ENDODONTICS, LLC | KJJ | 2023-06-25 |
| 00818365029006 | EdgeEndo® | US ENDODONTICS, LLC | KJJ | 2023-06-25 |
| 10818207024340 | SmearOFF System (PS System) | Vista Dental | KJJ | 2023-06-09 |
| 10818207024357 | PS System - Chlor-Xtra Plus Bag (40mL) | Vista Dental | KJJ | 2023-06-09 |
| 10818207024401 | PS System - Chlor-Xtra Plus Bag (60mL) | Vista Dental | KJJ | 2023-06-09 |
| 10818207024418 | PS System - Chlor-Xtra Plus Bag (100mL) | Vista Dental | KJJ | 2023-06-09 |
| 00860004740322 | HYBENX Advanced Dental Debridement Gel | Epien Medical, Inc. | KJJ | 2023-05-09 |
| 00860004740315 | HYBENX Advanced Dental Debridement | Epien Medical, Inc. | KJJ | 2023-05-08 |
| 00887919807223 | Brasseler USA | Peter Brasseler Holdings, LLC | KJJ | 2023-03-17 |
| 00887919807254 | Brasseler USA | Peter Brasseler Holdings, LLC | KJJ | 2023-03-17 |
| 00887919807285 | Brasseler USA | Peter Brasseler Holdings, LLC | KJJ | 2023-03-17 |
| 10850002458609 | Advance Dental Products | The Atlanta Dental Supply Company | KJJ | 2023-02-10 |
| 20850015491119 | Endocyn Root Canal Irrigation Solution | Sonoma Pharmaceuticals, Inc. | KJJ | 2022-12-02 |
| 20850015491140 | OroGenix Antiplaque Tooth Gel | Sonoma Pharmaceuticals, Inc. | KJJ | 2022-12-02 |