FDA UDI
In Commercial Distribution
🇺🇸 United States
AH Plus Endodontic Sealer Tubes
DI: D01060620110NA1
·
Model: 60620110NA
·
Dentsply De Trey GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AH Plus Endodontic Sealer Tubes
- Primary DI
- D01060620110NA1
- Version / Model
- 60620110NA
- Catalog Number
- 60620110NA
- Company Name
- Dentsply De Trey GmbH
- Labeler DUNS
- 315471722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-31
- Public Version
- 2
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- c7d9b1e4-49c6-49ee-b2f1-a8a95f2b6dc6
Device Description
AH Plus endodontic sealer in tubes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin for an easy manual mix. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KIF | RESIN, ROOT CANAL FILLING | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66609 | Dental epoxy resin | A substance intended for professional use as a dental root canal sealant that consists of a chemical-curing epoxy resin material(s); it does not include any additional hardening fillers/components (i.e., not a composite resin). It may be provided as a powder and/or paste intended to be mixed prior to application; dedicated disposable devices associated with application may be included with the resin. 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 | D01060620110NA1 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 8 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.