FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDICOM DENTICARE
DI: 10686864060953
·
Model: 10068
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
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Basic Information
- Brand Name
- MEDICOM DENTICARE
- Primary DI
- 10686864060953
- Version / Model
- 10068
- Catalog Number
- 10068
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2026-02-25
- Public Version
- 1
- Public Version Date
- 2026-03-05
- Public Version Status
- New
- Public Device Record Key
- 32e8137b-860f-4a1c-8527-4945286fd0d6
Device Description
Medicom DentiCare Spin DPA, Firm Cup - white
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46938 | Dental polishing cup, single-use | A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864060950 | GS1 | case | 6 | In Commercial Distribution | |
| Primary | 10686864060953 | GS1 | ||||
| Unit of Use | 00686864060956 | GS1 |
Customer Contacts
- Phone
- 1.800.361.2862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240950 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius