FDA UDI
In Commercial Distribution
🇺🇸 United States
dima Print Teeth & Temp
DI: J014660874260
·
Model: 66087426
·
Kulzer GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- dima Print Teeth & Temp
- Primary DI
- J014660874260
- Version / Model
- 66087426
- Catalog Number
- 66087426
- Company Name
- Kulzer GmbH
- Labeler DUNS
- 315666321
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-28
- Public Version
- 2
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- 3d0192cd-c01e-4e3a-b393-6f81c805ba36
Device Description
dima Print Teeth & Temp A3/A3.5 1000g
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- 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 |
|---|---|---|---|---|
| PZY | Additively manufactured, preformed, resin denture tooth | Dental | 872.3590 | 2 |
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63591 | Dental acrylic resin | A non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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 | J014660874260 | HIBCC |
Customer Contacts
- Phone
- +1(574)291-0661
- [email protected]