FDA UDI
In Commercial Distribution
🇺🇸 United States
DD Ti-Base 2CUT noLock
DI: EDDIDDDEVNL36S1
·
Model: DEV 36 Set
·
Dental Direkt GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DD Ti-Base 2CUT noLock
- Primary DI
- EDDIDDDEVNL36S1
- Version / Model
- DEV 36 Set
- Catalog Number
- DDDEVNL36S
- Company Name
- Dental Direkt GmbH
- Labeler DUNS
- 313214171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 3
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- 6cc32f79-cc77-4a12-822c-533b5475e980
Device Description
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. The Dental Direkt Ti-Base 2CUT noLock serves as a titanium bonding base for individualized bridge and bar restorations. The titanium bonding bases are available for various implant systems and consist of a prefabricated implant connection (interface), screw channel, a circumferential platform for designing the emergence profile and a shortenable cylinder for individualized patient care.
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44879 | Dental implant suprastructure, permanent, preformed | A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EDDIDDDEVNL36S1 | HIBCC |
Customer Contacts
- Phone
- +495225863190
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230218 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Interface: 3.6mm; Compatible with DENTSPLY Implants® Astra EV system |