FDA UDI
In Commercial Distribution
🇺🇸 United States
ActaCal Calcium Hydroxide Paste
DI: 00850440008582
·
Model: ACP
·
Engineered Endodontics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ActaCal Calcium Hydroxide Paste
- Primary DI
- 00850440008582
- Version / Model
- ACP
- Company Name
- Engineered Endodontics, LLC
- Labeler DUNS
- 079892178
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-02
- Public Version
- 1
- Public Version Date
- 2026-01-12
- Public Version Status
- New
- Public Device Record Key
- 1fd3fa4b-c9d8-456d-a4d3-e1797641ff2f
Device Description
Calcium Hydroxide Paste
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | 872.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62199 | Calcium hydroxide dental cement | A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. 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 | 00850440008582 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212475 | 000 |