FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Caulk® Orthodontic Resin
DI: D0026510030
·
Model: 651003
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Caulk® Orthodontic Resin
- Primary DI
- D0026510030
- Version / Model
- 651003
- Catalog Number
- 651003
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2022-10-03
- Public Version Status
- Update
- Public Device Record Key
- 7ef8b89d-bf35-4d09-8007-9e73a1b13fae
- Distribution End Date
- 2021-08-01
Device Description
Caulk® Orthodonic Resin, Liquid, Clear, 430ml Refill
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31783 | Temporary dental crown/bridge | A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0026510030 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 Bottle Liquid (430mL) - Clear | ||
| Total Volume | 430 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.