FDA UDI
In Commercial Distribution
🇺🇸 United States
InterActive® Implant
DI: 10841307100447
·
Model: 654308
·
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- InterActive® Implant
- Primary DI
- 10841307100447
- Version / Model
- 654308
- Catalog Number
- 654308
- Company Name
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Labeler DUNS
- 868856969
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 4
- Public Version Date
- 2024-12-17
- Public Version Status
- Update
- Public Device Record Key
- d76062b4-6976-4e1a-af72-9e99b7468a09
Device Description
Ø4.3 x 8 Platform 3.4mmD (RP) Conical
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55847 | Dental implant system | A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841307100447 | GS1 |
Customer Contacts
- Phone
- 1-888-649-6425
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130572 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4.3mmD x 8mmL |