510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PWLClass I

Oral Surgery Tray

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

PWL is the FDA product code for Oral Surgery Tray, a class I device type, regulated under 21 CFR 872.4565. FDA's definition for this code reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is...". As of , FDA records hold no 510(k) clearances under this code and 15 recalls.

Classification record

Product code
PWL
Device name
Oral Surgery Tray
FDA definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
15

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order