Identity
- Trade Name
- A. Titan Instruments FDA UDI
- Generic Name
- Gingival retraction cord packing tool FDA UDI
- Device Name
- #174 Fischer’s Ultrapack Packer 90 SM WH FDA UDI
- Model / Reference
- ULTRA 90010 FDA UDI
- Description
- #174 Fischer’s Ultrapack Packer 90 SM WH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841685105129 FDA UDI
- 510(k) Number
- K981596 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction cord packing tool FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Gingival retraction cord packing tool
A. Titan Instruments by A.Titan Instruments — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K981596 also covers:
- A. Titan Instruments — A.Titan Instruments
- A. Titan Instruments — A.Titan Instruments
- First String Advanced Braided Retraction Cord Non-Impregnated - Extra Small — Den-Mat Holdings, LLC
- First String Advanced Braided Retraction Cord Non-Impregnated - Large — Den-Mat Holdings, LLC
- First String Advanced Braided Retraction Cord Non-Impregnated - Medium — Den-Mat Holdings, LLC
- First String Advanced Braided Retraction Cord Non-Impregnated - Small — Den-Mat Holdings, LLC
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- A.Titan Instruments
Sources (1)
- FDA UDI 2115944a-0859-4f4a-a2f1-99ed2868fe1a 34 fields · synced Jun 9, 2026