FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Overdenture Comfort Cap (2 pieces)
DI: 10841307114239
·
Model: 4000-13
·
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Overdenture Comfort Cap (2 pieces)
- Primary DI
- 10841307114239
- Version / Model
- 4000-13
- Catalog Number
- 4000-13
- Company Name
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Labeler DUNS
- 868856969
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 6
- Public Version Date
- 2021-12-31
- Public Version Status
- Update
- Public Device Record Key
- df7539b2-6f23-497b-9787-d5561b22f742
- Distribution End Date
- 2021-12-31
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 44880 | Dental implant suprastructure, temporary, preformed, single-use | A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841307114239 | GS1 | ||||
| Unit of Use | 00841307114232 | GS1 |
Customer Contacts
- Phone
- 1-888-649-6425
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060063 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Platform: 5.0mm |