FDA UDI
In Commercial Distribution
🇺🇸 United States
Dam Punch 1PK
DI: D990DP1PK0
·
Model: DP1PK
·
SMART DENTURE CONVERSIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dam Punch 1PK
- Primary DI
- D990DP1PK0
- Version / Model
- DP1PK
- Company Name
- SMART DENTURE CONVERSIONS, LLC
- Labeler DUNS
- 010613514
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-19
- Public Version
- 2
- Public Version Date
- 2025-06-11
- Public Version Status
- Update
- Public Device Record Key
- f79c1cae-82f4-41b6-9b70-c8648fc65f7b
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35553 | Rubber dam punch | A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D990DP1PK0 | HIBCC |
Customer Contacts
- Phone
- 8555500707
- [email protected]