Identity
- Trade Name
- ACU-flow PUTTY BASE + CATALYST KIT FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. FDA UDI
- Model / Reference
- PK901 FDA UDI
- Description
- An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D811PUTTYVPSKITPK9010 FDA UDI
- 510(k) Number
- K053018 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 610 Milliliter FDA UDI
Category: Silicone dental impression material
ACU-flow PUTTY BASE + CATALYST KIT by Rainbow Specialty & Health Products Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Cleared under the same submission
K053018 also covers:
- Acu-Flow™ Best-Bite Bite Registration — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Bite Registration — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Bite Registration — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Heavy Body — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Heavy Body — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Light Body 6pk — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Light Body Plus — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Medium Body — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Monophase — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Putty Kit — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Rigid Tray — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Acu-Flow™ Rigid Tray — CLINICIAN'S CHOICE DENTAL PRODUCTS, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Rainbow Specialty & Health Products Inc
Sources (1)
- FDA UDI 0e609b1d-a600-4199-9fa4-f882998cab88 35 fields · synced Jun 1, 2026