FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL TRAY, STERILE, DISPOSABLE
K Number: K974238
·
Decision Feb 4, 1998
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
44
Review Days
84
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Basic Information
- Device Name
- DENTAL TRAY, STERILE, DISPOSABLE
- K Number
- K974238
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trinity Laboratories, Inc.
- Date Received
- November 12, 1997
- Decision Date
- February 4, 1998
- Product Code
- EIA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Trinity Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981441 | HEART CATH TRAY, STERILE, DISPOSABLE | Jul 10, 1998 | Substantially Equivalent |
| K974286 | CIRCUMCISION TRAY, CAT. NO. 70340 | Dec 12, 1997 | Substantially Equivalent |
| K972160 | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST | Aug 1, 1997 | Substantially Equivalent |
| K970722 | EYE TRAY | Mar 31, 1997 | Substantially Equivalent |
| K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | Feb 14, 1997 | Unknown |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Jan 22, 1997 | Substantially Equivalent |
| K953929 | MID-STREAM COLLECTION SET-STERILE | Nov 16, 1995 | Substantially Equivalent |
| K952058 | STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE | Sep 21, 1995 | Substantially Equivalent |
| K953070 | WOUNDFOAM 4 X 4 | Sep 8, 1995 | Substantially Equivalent |
| K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Jul 3, 1995 | Substantially Equivalent |