FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Calm-it™ Desensitizer
DI: D00261A0041
·
Model: 61A004
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
40
Basic Information
- Brand Name
- Calm-it™ Desensitizer
- Primary DI
- D00261A0041
- Version / Model
- 61A004
- Catalog Number
- 61A004
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2023-12-13
- Public Version Status
- Update
- Public Device Record Key
- 681a7a6f-8e92-4378-bd60-094e63c283f4
- Distribution End Date
- 2019-01-15
Device Description
Calm-It™ Desensitizer Unit Dose Refill
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | D00261A00432 | HIBCC | Case | 3 | Not in Commercial Distribution | 2019-01-15 |
| Primary | D00261A0041 | HIBCC | ||||
| Unit of Use | D00261A0040 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 40 Unit Doses and 1 Unit Dose Holder |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.