FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Calm-it™ Desensitizer
DI: D00261A1001
·
Model: 61A100
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Calm-it™ Desensitizer
- Primary DI
- D00261A1001
- Version / Model
- 61A100
- Catalog Number
- 61A100
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-24
- Public Version
- 2
- Public Version Date
- 2024-06-05
- Public Version Status
- Update
- Public Device Record Key
- a3c38197-4c80-43a5-ba9b-6b7689a10e79
- Distribution End Date
- 2024-06-05
Device Description
Calm-it™ Unit Dose Sample
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LBH | VARNISH, CAVITY | Dental | 872.3260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35698 | Dental cavity varnish | A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. 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 | D00261A1001 | HIBCC |
Customer Contacts
- Phone
- +1(800)583-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 Calm-it™ Desensitizer Unit Dose |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight.