Health-Tec Pit & Fissure Sealant
- Primary DI
- D773950100601
- Brand
- Health-Tec Pit & Fissure Sealant
- Company
- Dental Health Products Inc
- Model
- 950-10060
- Catalog number
- 950-10060
- Device description
- Health-Tec Pit & Fissure Sealant, Kit
- Published
- 2017-01-30
- Public version status
- Update
- 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 |
|---|
| EBC | Sealant, Pit And Fissure, And Conditioner |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D773950100601 | Primary | HIBCC | 0 | |
| D773950100600 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 32 Degrees Fahrenheit | 86 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 623191194
- Device count
- 4
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- true
- 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
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|---|
| D7735901000721 | DHP/Health-Tec Sterilization Tape | 590-100072 | 590-100072 | 2023-03-24 |
| D7735901000821 | DHP/Health-Tec Sterilization Tape | 590-100082 | 590-100082 | 2023-03-24 |
| D7736001000320 | DHP/Health-Tec Sterilization Pouches | 600-100032 | 600-100032 | 2023-03-23 |
| D7736001000420 | DHP/Health-Tec Sterilization Pouches | 600-100042 | 600-100042 | 2023-03-23 |
| D7736001000520 | DHP/Health-Tec Sterilization Pouches | 600-100052 | 600-100052 | 2023-03-23 |
| D7736001000620 | DHP/Health-Tec Sterilization Pouches | 600-100062 | 600-100062 | 2023-03-23 |
| D7736001000720 | DHP/Health-Tec Sterilization Pouches | 600-100072 | 600-100072 | 2023-03-23 |
| D7736001000820 | DHP/Health-Tec Sterilization Pouches | 600-100082 | 600-100082 | 2023-03-23 |
| D7736001000920 | DHP/Health-Tec Sterilization Pouches | 600-100092 | 600-100092 | 2023-03-23 |
| D7736001001020 | DHP/Health-Tec Sterilization Pouches | 600-100102 | 600-100102 | 2023-03-23 |
| D7736001001120 | DHP/Health-Tec Sterilization Pouches | 600-100112 | 600-100112 | 2023-03-23 |
| D773970100010 | Health-Tec/DHP Disposable Prophy Angles | 970-10001 | 970-10001 | 2022-11-28 |
| D773970100020 | Health-Tec/DHP Disposable Prophy Angles | 970-10002 | 970-10002 | 2022-11-28 |
| D7739705220140 | Health-Tec/DHP Disposable Prophy Angles | 970-522014 | 970-522014 | 2022-11-28 |
| D773970522140 | Health-Tec/DHP Disposable Prophy Angles | 970-522114 | 970-522114 | 2022-11-28 |
| D7739705224140 | Health-Tec/DHP Disposable Prophy Angles | 970-522414 | 970-522414 | 2022-11-28 |
| D7739705225140 | Health-Tec/DHP Disposable Prophy Angles | 970-522514 | 970-522514 | 2022-11-28 |
| D773930100060 | Health-Tec/DHP PSP Barrier Envelopes | 930-10006 | 930-10006 | 2022-11-14 |
| D773930HTBWT0 | Health-Tec/DHP Bite Wing Tabs | 930-HTBWT | 930-HTBWT | 2022-11-14 |
| D773800100020 | Health-Tec/DHP Matrix Bands | 800-10002 | 800-10002 | 2022-11-10 |
Other Devices Sharing Product Codes
dhpi.net